Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 53
- Latest Decision
- 2026-01-28
Clearances · page 4 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K252164 | NorthStar Mapping System | Imricor Medical Systems | DQK | Class II | 2026-01-28 |
| K251670 | MAC 7 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | DPS | Class II | 2026-01-26 |
| K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0) | Boston Scientific Cardiac Diagnostic Technologies, Inc. | DSI | Class II | 2026-01-23 |
| K252984 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | DRG | Class II | 2026-01-22 |
| K253652 | Genie MAX Large Bore Introducer Sheath | Cultiv8 1, LLC | DYB | Class II | 2026-01-22 |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) | Merit Medical Ireland, Ltd. | DQX | Class II | 2026-01-21 |
| K253730 | RoVo Mechanical Thrombectomy System | Verge Medical, Inc. | QEW | Class II | 2026-01-21 |
| K253998 | Clearview Intracoronary Shunts | Medtronic, Inc. | DWF | Class II | 2026-01-20 |
| K251318 | VariFuse Adjustable Infusion Catheter | Argon Medical Devices, Inc. | QEY | Class II | 2026-01-20 |
| K254085 | CARTO 3 EP Navigation System V9.0 with PIU Plus | Biosense Webster, Inc. | DQK | Class II | 2026-01-18 |
| K254114 | Baylis Connector Cable | Baylis Medical Technologies, Inc. | DSA | Class II | 2026-01-18 |
| K251970 | Sprinter Legend Rapid Exchange Balloon Dilatation Catheter | Medtronic, Ireland | LOX | Class II | 2026-01-17 |
| K251744 | Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter | Medtronic | DTM | Class II | 2026-01-16 |
| K251367 | OptoMonitor 3 | Opsens, Inc. | DXO | Class II | 2026-01-16 |
| K250135 | WAVE Clinical Platform (2.0.000) | Baxter Healthcare Corp/ Excel Medical | MWI | Class II | 2026-01-16 |
| K252297 | Toro 88 Superbore Catheter | Toro Neurovascular, Inc. | QJP | Class II | 2026-01-16 |
| K251357 | Esperance pHLO Aspiration System | Phenox, Ltd. | NRY | Class II | 2026-01-15 |
| K253925 | Aventus Thrombectomy System | Inquis Medical | QEZ | Class II | 2026-01-15 |
| K251831 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | QHW | Class II | 2026-01-15 |
| K253511 | Concerto Versa Detachable Coil | Medtronic, Inc. | KRD | Class II | 2026-01-14 |
| K251307 | Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) | Shenzhen Hingmed Medical Instrument Co., Ltd. | DXN | Class II | 2026-01-12 |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N) | Unimed Medical Supplies, Inc. | DXQ | Class II | 2026-01-09 |
| K252589 | Corvair Monza | AliveCor, Inc. | MHX | Class II | 2026-01-09 |
| K253142 | Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) | Ningbo Ranor Medical Technology Co., Ltd. | DXN | Class II | 2026-01-09 |
| K252674 | Solo Pace Fusion System (SOLOFUSE1) | Solo Pace, Inc. | DQX | Class II | 2026-01-09 |
| K252794 | Vision-MR Diagnostic Catheter | Imricor Medical Systems, Inc. | DRF | Class II | 2026-01-08 |
| K250305 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health | PNE | Class II | 2026-01-07 |
| K251207 | Sangria Thrombectomy System | Avantec Vascular Corporation | QEW | Class II | 2026-01-07 |
| K253109 | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) | Shenzhen Best Electronics Co., Ltd. | DQA | Class II | 2026-01-07 |
| K251097 | V-DAC Catheter | Vesalio, Inc. | QJP | Class II | 2026-01-06 |
| K251668 | SurfRider 13 Microcatheter | Kaneka Americas Holding, Inc. | QJP | Class II | 2026-01-05 |
| K243627 | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) | Arc Trauma, LLC | DXC | Class II | 2025-12-31 |
| K252361 | AccurECG Analysis System (v2.0) | Accurkardia, Inc. | DPS | Class II | 2025-12-22 |
| K251783 | Inspire HCR and HCR DUAL cardiotomy reservoirs | Sorin Group Italia S.R.L. | DTN | Class II | 2025-12-22 |
| K250756 | Pression Wave PRO External Counter-Pulsation System | Pression, Inc. | DRN | Class II | 2025-12-22 |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) | Medtronic, Inc. | DQY | Class II | 2025-12-19 |
| K251143 | Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) | Ningbo Ranor Medical Science & Technology Co., Ltd. | DXN | Class II | 2025-12-19 |
| K251751 | Spo2 Sensor CSS032D | Shenzhen Ykd Technology Co., Ltd. | DQA | Class II | 2025-12-19 |
| K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer | Surgical Instrument Service and Savings, Inc. | PNE | Class II | 2025-12-19 |
| K252284 | eMurmur Heart AI | Csd Labs | DQD | Class II | 2025-12-19 |
| K253733 | STAR Apollo Mapping System | Rhythm AI, Ltd. | DQK | Class II | 2025-12-19 |
| K253616 | ProtekDilate Vascular Access Kit | Sorin Group Italia S.R.L. | DRE | Class II | 2025-12-19 |
| K252956 | Helo Thrombectomy System | Endovascular Engineering, Inc. | QEW | Class II | 2025-12-18 |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | DQK | Class II | 2025-12-18 |
| K251915 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | LIT | Class II | 2025-12-18 |
| K253516 | Assert-IQ (DM5100) | ABBOTT MEDICAL | MXD | Class II | 2025-12-18 |
| K252508 | Intri26 Introducer Sheath | Inari Medical, Inc. | DYB | Class II | 2025-12-17 |
| K252417 | Amplatzer Piccolo Delivery System (9-PDS-04F-045) | ABBOTT MEDICAL | DQY | Class II | 2025-12-17 |
| K250854 | Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro) | Shenzhen Comen Medical Instruments Co.,Ltd | MHX | Class II | 2025-12-17 |
| K252204 | prolaio eVO2peak Module (Version 1.0) | Prolaio, Inc. | PPW | Class II | 2025-12-16 |
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) | Baxter Healthcare Corporation | DXQ | Class II | 2025-12-16 |
| K253741 | VStick Vascular Access Set | Argon Medical Devices, Inc. | DYB | Class II | 2025-12-15 |
| K253677 | Tembo Embolic System | Instylla, Inc. | KRD | Class II | 2025-12-15 |
| K250974 | Bio Arterial Deluxe (IC-BAP-DX) | Bio Compression Systems, Inc. | JOW | Class II | 2025-12-12 |
| K250821 | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) | Eurosets S.R.L | DTZ | Class II | 2025-12-12 |
| K253141 | DeepRhythmAI | Medicalgorithmics S.A. | DQK | Class II | 2025-12-11 |
| K250190 | Sequential Compression System (SCD600) | Shenzhen Comen Medical Instruments Co.,Ltd | JOW | Class II | 2025-12-08 |
| K250258 | HeartBeam AIMIGo with 12-L ECG Synthesis Software System | Heartbeam, Inc. | DXH | Class II | 2025-12-08 |
| K243438 | MEMO Patch M (MPT-E08R-UNC01) | Huinno Co., Ltd. | DXH | Class II | 2025-12-05 |
| K252126 | MitraPatch Mitral Valve Repair System | Chawla Heart Technologies, LLC | PAW | Class II | 2025-12-04 |
| K252429 | Vektor Computational ECG Mapping System (vMap®) | Vektor Medical, Inc. | DQK | Class II | 2025-12-04 |
| K253293 | VitaloJAK Clinic (Model 7100) | Vitalograph , Ltd. | DSH | Class II | 2025-12-03 |
| K252213 | Bendit17 Microcatheter | Bend IT Technologies, Ltd. | QJP | Class II | 2025-12-03 |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08) | Unimed Medical Supplies, Inc. | DQA | Class II | 2025-12-01 |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) | Unimed Medical Supplies, Inc. | DQA | Class II | 2025-12-01 |
| K252827 | IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559) | Drägerwerk AG & Co. KGaA | DSA | Class II | 2025-12-01 |
| K252405 | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter | Surgical Instrument Service and Savings, Inc. | NLH | Class II | 2025-11-26 |
| K253168 | 0.014 Willow Guidewire | Arbor Endovascular, LLC | MOF | Class II | 2025-11-26 |
| K251070 | Akura Thrombectomy System | Akura Medical | QEW | Class II | 2025-11-25 |
| K250635 | FEops HEARTguide Simulation Application | Feops NV | QQI | Class II | 2025-11-25 |
| K242503 | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) | Eurosets S.R.L | DTZ | Class II | 2025-11-24 |
| K253407 | NeVa PV Thrombectomy Device | Vesalio, Inc. | QEX | Class II | 2025-11-24 |
| K250634 | BCM2-Body Composition Monitor | Fresenius Medical Care Renal Therapies Group, LLC | DSB | Class II | 2025-11-24 |
| K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885 | AngioDynamics, Inc. | QEZ | Class II | 2025-11-24 |
| K251293 | CardioVision | Icardio.Ai | QUO | Class II | 2025-11-21 |
| K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) | Remington Medical, Inc. | DPW | Class II | 2025-11-20 |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) | Medline Industries, LP | DXC | Class II | 2025-11-20 |
| K251693 | Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75) | Unimed Medical Supplies, Inc. | DQA | Class II | 2025-11-18 |
| K252281 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | IZQ | Class II | 2025-11-18 |
| K243981 | Hexoskin Medical System (7100-00016) | Carre Technologies, Inc. | DXH | Class II | 2025-11-18 |
| K251695 | Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06) | Unimed Medical Supplies, Inc. | DQA | Class II | 2025-11-18 |
| K252592 | TELLTALE Electrosurgical Guidewire System | Telltale, LLC | SGO | Class II | 2025-11-13 |
| K251006 | NeVasc Aspiration System | Vesalio, Inc. | NRY | Class II | 2025-11-10 |
| K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) | Philips Medizin Systeme Böblingen GmbH | MHX | Class II | 2025-11-10 |
| K252474 | Withings BeamO (SCT02) | Withings | DPS | Class II | 2025-11-10 |
| K251596 | Lunderquist Extra Stiff Wire Guide | William Cook Europe Aps | DQX | Class II | 2025-11-09 |
| K251295 | ulrichINJECT CT Motion (XD 8000) | Ulrich GmbH & Co. KG | IZQ | Class II | 2025-11-07 |
| K251792 | Stereotaxis GenesisX RMN with Navigant Workstation (NWS) | Stereotaxis, Inc. | DXX | Class II | 2025-11-06 |
| K252046 | Zoom System (Zoom 4S Catheter) | Imperative Care, Inc. | NRY | Class II | 2025-10-30 |
| K250632 | Arctx Cool Catheter Set | Arctx Medical | PLA | Class II | 2025-10-30 |
| K253376 | OBSIDIO Conformable Embolic (M0013972101010) | Boston Scientific Corporation | KRD | Class II | 2025-10-30 |
| K252390 | Telescope Guide Extension Catheter | Medtronic, Ireland | DQY | Class II | 2025-10-29 |
| K253323 | Protrieve Sheath | Inari Medical | QEW | Class II | 2025-10-29 |
| K253232 | Seguin Annuloplasty Ring | ABBOTT MEDICAL | KRH | Class II | 2025-10-29 |
| K251466 | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr | Wellell, Inc. | JOW | Class II | 2025-10-28 |
| K253399 | Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter | Volcano Corporation (Dba Philips Image Guided Therapy Device | OBJ | Class II | 2025-10-28 |
| K251331 | Blood Pressure Monitor (B73, BE23T) | Shenzhen Jamr Technology Co., Ltd. | DXN | Class II | 2025-10-27 |
| K251372 | VersaD Delivery Catheter | Unity Medical, Inc. | QJP | Class II | 2025-10-24 |
| K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | DQK | Class II | 2025-10-24 |
| K251974 | Arctic Sun Temperature Management System (Model 5000) | Medivance, Inc. | DWJ | Class II | 2025-10-24 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.