Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 52
- Latest Decision
- 2025-10-24
Clearances · page 5 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K253106 | AngioVac Cannula | AngioDynamics, Inc. | DWF | Class II | 2025-10-24 |
| K251312 | Vesalio Peripheral System | Vesalio, Inc. | QEZ | Class II | 2025-10-24 |
| K252238 | CoroFlow Cardiovascular System | Coroventis Research AB | DQK | Class II | 2025-10-24 |
| K252309 | PerQseal Introducers | Vivasure Medical Limited | DYB | Class II | 2025-10-23 |
| K250955 | XC11 ICE System, USA | Yorlabs, Inc. | OBJ | Class II | 2025-10-22 |
| K252569 | Carrier XL Delivery Catheter | Balt USA, LLC | QJP | Class II | 2025-10-22 |
| K251185 | Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) | Intervene | QEW | Class II | 2025-10-22 |
| K251838 | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | DYB | Class II | 2025-10-21 |
| K253034 | HemoSphere Stream Module | Edwards Lifesciences | DQK | Class II | 2025-10-21 |
| K252277 | Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) | Vascular Flow Technologies Limited | DSY | Class II | 2025-10-20 |
| K251146 | IntelliVue Patient monitors MX400, MX450, MX500, MX550 | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | 2025-10-17 |
| K250203 | SureAx-Guide | Sureax Medical, LLC | DQX | Class II | 2025-10-17 |
| K243727 | Re:Balans | Mode Sensors AS | DSB | Class II | 2025-10-16 |
| K252612 | INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing | Penumbra, Inc. | QEW | Class II | 2025-10-16 |
| K250979 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) | Zoll Circulation, Inc. | NZE | Class II | 2025-10-15 |
| K253099 | LIFEPAK 15 AC Power Adapter (41577-000333) | Physio-Control, Inc. | MPD | Class II | 2025-10-14 |
| K251795 | Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) | Honsun (Nantong) Co., Ltd. | DXN | Class II | 2025-10-09 |
| K252766 | 14Fr Low Profile Introducer Kit | Abiomed, Inc. | DYB | Class II | 2025-10-08 |
| K251603 | Tigertriever 17 Ultra Revascularization Device | Rapid Medical Ltd. | NRY | Class II | 2025-10-06 |
| K250031 | Amplatzer Guidewire | ABBOTT MEDICAL | DQX | Class II | 2025-10-03 |
| K252769 | Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) | Shenzhen Finicare Co., Ltd. | DXN | Class II | 2025-10-02 |
| K252440 | EasyTeleMed (2.0.2) | Ingeniars S.R.L. | DRG | Class II | 2025-10-02 |
| K252722 | Biopsy Forceps | Fehling Instruments GmbH | DWZ | Class II | 2025-09-30 |
| K243270 | TigerConnect Alarm Management | Tigerconnect | MSX | Class II | 2025-09-30 |
| K251669 | IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter | Shanghai Draeger Medical Instrument Co., Ltd. | DSA | Class II | 2025-09-30 |
| K252441 | Primero Safe Access System | South53, LLC | DYB | Class II | 2025-09-29 |
| K251275 | VitalStream ART Connect; VitalStream-Hemo | Caretaker Medical | DXG | Class II | 2025-09-26 |
| K251789 | EMBOTRAP III Revascularization Device | Neuravi Limited | NRY | Class II | 2025-09-25 |
| K250837 | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. | DQA | Class II | 2025-09-25 |
| K252013 | EnSite X EP System | ABBOTT MEDICAL | DQK | Class II | 2025-09-25 |
| K252689 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) | Imaxeon Pty, Ltd. | IZQ | Class II | 2025-09-24 |
| K252227 | Pounce(TM) Sheath | Surmodics,Inc. | DYB | Class II | 2025-09-24 |
| K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900) | Edwards Lifesciences, LLC | KRH | Class II | 2025-09-23 |
| K250209 | Polyvinyl Alcohol Embolic Microspheres | Canyon Medical, Inc. | KRD | Class II | 2025-09-23 |
| K252315 | Santreva-ATK Endovascular Revasculariztion Catheter | AngioSafe, Inc. | PDU | Class II | 2025-09-22 |
| K250649 | Bunkerhill ECG-EF | BunkerHill Health | QYE | Class II | 2025-09-19 |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450) | Edwards Lifesciences, LLC | KRH | Class II | 2025-09-17 |
| K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | Abbott | MXD | Class II | 2025-09-17 |
| K251446 | PlasmaFlow X Compression Sleeve Device (XPF0001) | Manamed, LLC | JOW | Class II | 2025-09-17 |
| K252027 | Vertex(TM) Catheter | Jupiter Endovascular | DYB | Class II | 2025-09-12 |
| K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) | Boston Scientific Corporation | MXD | Class II | 2025-09-12 |
| K251518 | Volta AF-Xplorer II | Volta Medical | DQK | Class II | 2025-09-12 |
| K252595 | Stethophone Pro | Sparrow Acoustics, Inc. | DQD | Class II | 2025-09-12 |
| K251158 | PowerWire® 14 Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. | PDU | Class II | 2025-09-11 |
| K250507 | Hypertension Notification Feature (HTNF) | Apple, Inc. | SFR | Class II | 2025-09-11 |
| K252527 | Surfacer Inside-Out Access Catheter System | Merit Medical System, Inc. | QJH | Class II | 2025-09-10 |
| K250922 | Edema Guard Monitor (EGM) CardioSet-001 | Cardioset Medical , Ltd. | DSB | Class II | 2025-09-09 |
| K250960 | DUO Microcatheter | Rev Neuro, LLC | QJP | Class II | 2025-09-08 |
| K244038 | High Pressure Tubing | Shandong Int Medical Instruments Co., Ltd. | DXT | Class II | 2025-09-05 |
| K243795 | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | MJN | Class II | 2025-09-05 |
| K243789 | LIBERTY Endovascular Robotic System (LIBERTYOS) | Microbot Medical , Ltd. | DXX | Class II | 2025-09-04 |
| K251463 | EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) | ABBOTT MEDICAL | DQK | Class II | 2025-09-04 |
| K250231 | Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856) | Dongguan E-Test Technology Co., Ltd. | DXN | Class II | 2025-09-03 |
| K250765 | AViTA Arm Type Blood Pressure Monitor Cuff | Avita Corporation | DXQ | Class II | 2025-09-03 |
| K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) | Philips Medizin Systeme Böblingen GmbH | MHX | Class II | 2025-09-02 |
| K252364 | Edwards eSheath Optima introducer set | Edwards Lifesciences | DYB | Class II | 2025-08-29 |
| K251181 | Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT) | Merit Medical Ireland, Ltd. | DQX | Class II | 2025-08-29 |
| K252392 | Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. | NRY | Class II | 2025-08-29 |
| K252057 | Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System | Imperative Care, Inc. | QEW | Class II | 2025-08-28 |
| K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) | Fysicon BV | MWI | Class II | 2025-08-27 |
| K252419 | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical, Inc. | DXF | Class II | 2025-08-27 |
| K243687 | Vital Signs | Oxehealth Limited | QME | Class II | 2025-08-27 |
| K244061 | X-Wire Guidewire | Imperative Care, Inc. | MOF | Class II | 2025-08-26 |
| K251277 | CoraForce Microcatheter, CoraFlex Microcatheter | Reflow Medical, Inc. | DQY | Class II | 2025-08-22 |
| K251828 | CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | NRY | Class II | 2025-08-22 |
| K252302 | CARTO 3 EP Navigation System V8.1 | Biosense Webster, Inc. | DQK | Class II | 2025-08-22 |
| K250147 | CPS Locator 3D Delivery Catheter | Centerpoint Systems | DQY | Class II | 2025-08-22 |
| K251086 | PnueAira (PNCU-01) | Biotab, LLC | JOW | Class II | 2025-08-18 |
| K243650 | Zio® monitor (DFG0001) | iRhythm Technologies, Inc. | DSH | Class II | 2025-08-15 |
| K250931 | Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121) | Unimed Medical Supplies, Inc. | DQA | Class II | 2025-08-13 |
| K251494 | Eko Foundation Analysis Software with Transformers (EFAST) | Eko Health, Inc. | DQD | Class II | 2025-08-12 |
| K250817 | Coretech Compression System (Coretech RHB3003) | Vive Health, LLC | JOW | Class II | 2025-08-08 |
| K250569 | Cardiologs Holter Platform | Philips France Commercial | DPS | Class II | 2025-08-06 |
| K251120 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) | Microlife Corporation | DXN | Class II | 2025-08-06 |
| K251113 | iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr | Andon Health Co, Ltd. | DXN | Class II | 2025-08-04 |
| K251762 | Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) | Spectrum Medical S.R.L. | KFM | Class II | 2025-08-04 |
| K242728 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MSX | Class II | 2025-07-31 |
| K244007 | ArteVu | Cardio Ring Technologies, Inc. Taiwan Branch | DXN | Class II | 2025-07-30 |
| K251234 | EnSite X EP System | ABBOTT MEDICAL | DQK | Class II | 2025-07-30 |
| K243534 | Micro Catheter | Suzhou Zenith Vascular SciTech Limited | KRA | Class II | 2025-07-30 |
| K251364 | Sleepiz One+ (2.5) | Sleepiz AG | DRT | Class II | 2025-07-29 |
| K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | Edan Instruments, Inc. | MHX | Class II | 2025-07-29 |
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) | Infobionic, Inc. | DSI | Class II | 2025-07-29 |
| K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Anumana, Inc. | QYE | Class II | 2025-07-28 |
| K250552 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | ABBOTT MEDICAL | DQX | Class II | 2025-07-25 |
| K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. | KRH | Class II | 2025-07-25 |
| K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) | Edwards Lifesciences | DQK | Class II | 2025-07-23 |
| K250590 | MAGiC Sweep EP Mapping Catheter | Stereotaxis, Inc. | DRF | Class II | 2025-07-23 |
| K243566 | CardioTag | Cardiosense, Inc. | DXR | Class II | 2025-07-22 |
| K250913 | TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System | Jiangsu Tingsn Technology Co., Ltd. | OBJ | Class II | 2025-07-19 |
| K250902 | HeartFlow Analysis | HeartFlow, Inc. | PJA | Class II | 2025-07-18 |
| K250751 | DualView Catheter | Terumo Corporation | DQO | Class II | 2025-07-17 |
| K243324 | Masimo O3 Regional Oximeter | Masimo Corporation | MUD | Class II | 2025-07-17 |
| K243756 | 0.014 Willow Guidewire | Arbor Endovascular, LLC | MOF | Class II | 2025-07-17 |
| K251102 | Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603) | Cemho Medical Technology (Guangdong) Co., Ltd. | DXN | Class II | 2025-07-16 |
| K250119 | Tempus ECG-Low EF | Tempus AI, Inc. | QYE | Class II | 2025-07-15 |
| K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N) | Unimed Medical Supplies, Inc. | DXQ | Class II | 2025-07-15 |
| K251488 | FLOWRUNNER Aspiration System | Expanse Medical, Inc. | QEZ | Class II | 2025-07-14 |
| K250185 | Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) | Jiangxi Aicare Medical Technology Co., Ltd. | DXN | Class II | 2025-07-14 |
| K241179 | Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) | VivaQuant, Inc. | QYX | Class II | 2025-07-11 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.