Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 42
- Latest Decision
- 2025-04-03
Clearances · page 7 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K243305 | Masimo W1 | Masimo Corporation | DPS | Class II | 2025-04-03 |
| K243733 | SION blue PLUS | Asahi Intecc Co., Ltd. | DQX | Class II | 2025-04-02 |
| K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire | Scientia Vascular, Inc. | MOF | Class II | 2025-04-01 |
| K250558 | SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) | Medtronic, Inc. | DQY | Class II | 2025-03-27 |
| K241962 | Crossloop | Asahi Intecc Co., Ltd. | DQX | Class II | 2025-03-27 |
| K244046 | Edwards eSheath Optima introducer set | Edwards Lifesciences | DYB | Class II | 2025-03-27 |
| K250542 | AC3 Range Intra-Aortic Balloon Pump | Arrow International, LLC | DSP | Class II | 2025-03-26 |
| K250668 | Aventus Thrombectomy System (IM-2100) | Inquis Medical | QEW | Class II | 2025-03-25 |
| K250225 | Bolt Intravascular Lithotripsy (IVL) System | Bolt Medical, Inc. | PPN | Class II | 2025-03-25 |
| K242893 | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System | Luma Vision Limited | OBJ | Class II | 2025-03-24 |
| K250013 | VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP) | Control Medical Technology, Inc. / Dba Ventiv Scientific | QEZ | Class II | 2025-03-24 |
| K241890 | Philips Holter Analysis System | Philips Medizin Systeme Böblingen GmbH | MLO | Class II | 2025-03-21 |
| K242289 | Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter | Stryker Neurovascular | QJP | Class II | 2025-03-21 |
| K242909 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | Edwards Lifesciences, LLC | DRS | Class II | 2025-03-21 |
| K243928 | ViaOne Epicardial Access System | Cardiovia , Ltd. | DYB | Class II | 2025-03-20 |
| K250468 | iSLEEVE Introducer Set | Boston Scientific | DYB | Class II | 2025-03-20 |
| K240933 | CarbonCool® System | Global Healthcare SG Sdn. Bhd | NZE | Class II | 2025-03-18 |
| K250439 | Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca | Contract Medical International, GmbH | DYB | Class II | 2025-03-16 |
| K250079 | Ruby XL System | Penumbra, Inc. | KRD | Class II | 2025-03-14 |
| K250091 | KOROT Blood Pressure Monitor (KOROT P3 Accurate) | Korot Co., Ltd. | DXN | Class II | 2025-03-14 |
| K250088 | FlowTriever2 Catheter | Inari Medical, Inc. | QEW | Class II | 2025-03-13 |
| K250385 | Turbo-Elite Laser Atherectomy Catheter | Spectranetics | MCW | Class II | 2025-03-13 |
| K241562 | OutFlo Aortic Valve Dilatation Balloon Catheter | Disa Medinotec | OZT | Class II | 2025-03-11 |
| K243101 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) | Surgical Instrument Service and Savings, Inc. | OWQ | Class II | 2025-03-10 |
| K243842 | Intra-Operative Positioning System (IOPS®) | Centerline Biomedical, Inc. | DQK | Class II | 2025-03-06 |
| K242597 | CROSSLEAD 0.018inch | Asahi Intecc Co., Ltd. | DQX | Class II | 2025-03-05 |
| K242876 | Pulse Oximeter ( PO2, PO2A, PO2B) | Shenzhen Viatom Technology Co., Ltd. | DQA | Class II | 2025-02-28 |
| K243436 | Seclusion Catheter | Basis Medical | DQY | Class II | 2025-02-28 |
| K243704 | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | LIT | Class II | 2025-02-27 |
| K241550 | Gelweave Vascular Prostheses | Vascutek, Ltd. | DSY | Class II | 2025-02-27 |
| K250012 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. | NRY | Class II | 2025-02-26 |
| K241576 | Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) | Infraredx, Inc. | OGZ | Class II | 2025-02-26 |
| K250202 | Aventus Thrombectomy System | Inquis Medical | QEW | Class II | 2025-02-26 |
| K233963 | Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) | Taiwan Aulisa Medical Devices Technologies, Inc. | DQA | Class II | 2025-02-25 |
| K242967 | Loss of Pulse Detection | Fitbit | SDY | Class II | 2025-02-25 |
| K243287 | APRO 70 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC | NRY | Class II | 2025-02-24 |
| K243115 | Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) | Shenzhen Urion Technology Co., Ltd. | DXN | Class II | 2025-02-21 |
| K243086 | Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91) | Unimed Medical Supplies, Inc. | DQA | Class II | 2025-02-20 |
| K243312 | CER-S | Cardiocalm Srl | DQK | Class II | 2025-02-20 |
| K242455 | AViTA Pulse Oximeter (SP62B) | Avita Corporation | DQA | Class II | 2025-02-19 |
| K241578 | Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) | Shenzhen Bsx Technology Electronics Co., Ltd. | DXN | Class II | 2025-02-19 |
| K243593 | AXS Lift Intracranial Base Catheter | Stryker Neurovascular | QJP | Class II | 2025-02-18 |
| K241958 | WARD-CSS (v1.2.x) | Ward 24/7 Aps | MWI | Class II | 2025-02-14 |
| K242776 | LimFlow V-Ceiver | LimFlow, Inc. | MMX | Class II | 2025-02-14 |
| K242104 | Penumbra System (Reperfusion Catheter RED 72) | Penumbra, Inc. | NRY | Class II | 2025-02-13 |
| K241479 | Etiometry Platform (DAV 5.4 RAE 9.2) | Etiometry, Inc. | PPW | Class II | 2025-02-12 |
| K241418 | OptoMonitor 3 | Opsens, Inc. | DXO | Class II | 2025-02-12 |
| K241634 | Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) | Guangdong Xinyu Electronic and Technology Co., Ltd. | DXN | Class II | 2025-02-11 |
| K243661 | Electronic Blood Pressure Monitor | Hetaida Technology Co., Ltd. | DXN | Class II | 2025-02-07 |
| K242580 | Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) | Unimed Medical Supplies, Inc. | DQA | Class II | 2025-02-06 |
| K241702 | CROSSLEAD 0.014inch | Asahi Intecc Co., Ltd. | DQX | Class II | 2025-02-06 |
| K242352 | Accurate Mini Non-invasive blood pressure monitor (AMB-001) | Accurate Meditech, Inc. | DXN | Class II | 2025-02-05 |
| K241590 | Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) | Guangdong Xinyu Electronic and Technology Co., Ltd. | DXN | Class II | 2025-02-03 |
| K243146 | iCare APP | Ihealth Labs, Inc. | MWI | Class II | 2025-02-03 |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter, | C.R. Bard, Inc. | LDF | Class II | 2025-01-31 |
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter | Gentuity, LLC | DQO | Class II | 2025-01-31 |
| K242568 | Wrist Blood Pressure Monitor (OHMS11, OHMS12) | Shenzhen Zhongkemingwang Telecommunications Software Corp. | DXN | Class II | 2025-01-30 |
| K242757 | Rotarex Atherectomy System | Bard Peripheral Vascular, Inc. | MCW | Class II | 2025-01-30 |
| K233956 | Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) | Taiwan Aulisa Medical Devices Technologies, Inc. | DQA | Class II | 2025-01-30 |
| K241728 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 | Murata Vios, Inc. | DXN | Class II | 2025-01-23 |
| K241199 | Rotatable Connector (5944RL) | Shenzhen Launch Electrical Co., Ltd. | LDF | Class II | 2025-01-23 |
| K243892 | Affera Integrated Mapping System | Medtronic, Inc. | DQK | Class II | 2025-01-17 |
| K242705 | Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500) | Medtronic, Inc. | LDF | Class II | 2025-01-17 |
| K242051 | VersaD Delivery Catheter | Unity Medical, Inc. | QJP | Class II | 2025-01-17 |
| K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn | Philips Medizin Systeme Böblingen GmbH | DSA | Class II | 2025-01-17 |
| K242608 | Embozene Color-Advanced Microspheres | Varian Medical Systems, Inc. | KRD | Class II | 2025-01-17 |
| K241217 | CloudHRV System (100-01-001) | Inmedix, Inc. | DPS | Class II | 2025-01-16 |
| K242229 | Micro Ace Gold Advanced Micro Access System | Merit Medical Systems, Inc. | DRE | Class II | 2025-01-15 |
| K242873 | Ventrax Delivery System | Merit Medical Systems, Inc. | DQY | Class II | 2025-01-15 |
| K241096 | Venera 608 Deep Vein Thrombosis (DVT) Prevention System | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | JOW | Class II | 2025-01-15 |
| K241066 | BB-613-BPM | Biobeat Technologies , Ltd. | DXN | Class II | 2025-01-14 |
| K243297 | APRO 70 Swift Catheter | Alembic, LLC | QJP | Class II | 2025-01-14 |
| K242672 | Zoom System | Imperative Care, Inc. | NRY | Class II | 2025-01-14 |
| K243577 | Radical the Dude 8F Guide Catheter | Maduro Medical, Inc. | QJP | Class II | 2025-01-14 |
| K241431 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193) | Joytech Healthcare Co. , Ltd. | DXN | Class II | 2025-01-13 |
| K242528 | Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298) | Shenzhen Ruiankang Technology Co., Ltd. | DXN | Class II | 2025-01-10 |
| K241781 | Solo Pace Control | Solo Pace, Inc. | DTE | Class II | 2025-01-10 |
| K242842 | ANNE View, Central Hub | Sibel Health, Inc. | MSX | Class II | 2025-01-08 |
| K242588 | COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) | OrbusNeich Medical (Shenzhen) Co., Ltd. | DQY | Class II | 2025-01-07 |
| K243049 | Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) | Hunan Accurate Bio-Medical Technology Co., Ltd. | DQA | Class II | 2025-01-02 |
| K241388 | Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | QJP | Class II | 2025-01-02 |
| K243224 | MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801) | ABBOTT MEDICAL | DQY | Class II | 2024-12-31 |
| K242376 | Next Generation Access Platform | Balt USA, LLC | QJP | Class II | 2024-12-30 |
| K240890 | PanopticAI Vital Signs | PanopticAI technologies Limited | QME | Class II | 2024-12-23 |
| K242143 | Angiography Injector | Shandong Int Medical Instruments Co., Ltd. | DXT | Class II | 2024-12-23 |
| K242953 | KIDS Arterial Filters | Sorin Group Italia S.R.L. | DTM | Class II | 2024-12-20 |
| K242644 | SENDERO MAX Delivery Catheter | Okami Medical, Inc. | DQY | Class II | 2024-12-20 |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | Welch Allyn, Inc. | MWI | Class II | 2024-12-20 |
| K241768 | Broadway 8 Catheter | Stryker Neurovascular | QJP | Class II | 2024-12-19 |
| K241637 | Echo Intracranial Base Catheter | Stryker Neurovascular | QJP | Class II | 2024-12-19 |
| K240885 | Shadow Catheter | Simpson Interventions, Inc. | DQY | Class II | 2024-12-19 |
| K241040 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | LIT | Class II | 2024-12-18 |
| K242662 | Falcon/Xpress (Falcon/Xpress) | Viasonix , Ltd. | JOP | Class II | 2024-12-18 |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000) | Philips Medizin Systeme Böblingen GmbH | DPS | Class II | 2024-12-17 |
| K240873 | TEMBO Embolic System | Instylla, Inc. | KRD | Class II | 2024-12-16 |
| K243493 | Agilis NxT Steerable Introducer Dual-Reach | ABBOTT MEDICAL | DYB | Class II | 2024-12-13 |
| K231424 | HeartBeam AIMIGo(TM) System | Heartbeam, Inc. | MWJ | Class II | 2024-12-13 |
| K243540 | Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) | Ge Medical Systems Information Technologies, Inc. | DQK | Class II | 2024-12-12 |
| K242033 | Access25 Delivery Microcatheter | Penumbra, Inc. | QJP | Class II | 2024-12-11 |
| K243216 | Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) | Analog Devices | MWI | Class II | 2024-12-10 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.