Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 47
- Latest Decision
- 2025-07-11
Clearances · page 6 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K250772 | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter | Surgical Instrument Service and Savings, Inc. | NLH | Class II | 2025-07-11 |
| K243252 | ZBPro Diagnostic | Zbeats, Inc. | DPS | Class II | 2025-07-10 |
| K250283 | RAP Femoral Venous Cannulae | LivaNova USA, Inc. | DWF | Class II | 2025-07-10 |
| K250133 | HARBOR Occlusion Device | Nuvascular, Inc. | KRD | Class II | 2025-07-09 |
| K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. | MHX | Class II | 2025-07-09 |
| K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) | Spectrum Medical , Ltd. | DTR | Class II | 2025-07-08 |
| K250105 | Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) | Aveera Medical, Inc. | MGZ | Class II | 2025-07-03 |
| K250415 | G0 Blood Pressure Monitoring System (G0) | Aktiia SA | DXN | Class II | 2025-07-02 |
| K250972 | Primum Hydrophilic Guiding Catheter | Pendracare | DQY | Class II | 2025-06-29 |
| K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) | Sorin Group Italia S.R.L. | DWF | Class II | 2025-06-27 |
| K250828 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | DQY | Class II | 2025-06-27 |
| K250310 | VIKING Fixed Curve Diagnostic Catheter | Boston Scientific Corporation | DRF | Class II | 2025-06-27 |
| K250548 | Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) | Joytech Healthcare Co. , Ltd. | DXN | Class II | 2025-06-26 |
| K250519 | Lap.Ox Laparoscopic Tissue Oximeter | ViOptix, Inc. | MUD | Class II | 2025-06-26 |
| K243184 | SAT CenterFlow Molding Balloon Catheter (IN20-00313) | Strait Access Technologies Holdings | DQY | Class II | 2025-06-25 |
| K250747 | Globe® Pulsed Field System | Kardium, Inc. | DQK | Class II | 2025-06-25 |
| K250326 | Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) | Spectrum Medical S.R.L. | KFM | Class II | 2025-06-24 |
| K251358 | Bridge Plus Occlusion Balloon (590-002) | Philips Image Guided Therapy Devices | MJN | Class II | 2025-06-24 |
| K251114 | FloPatch FP120 | Flosonics Medical | DPW | Class II | 2025-06-20 |
| K250151 | Us2.ca | Eko.Ai Pte Ltd. D/B/A Us2.Ai | SDJ | Class II | 2025-06-20 |
| K242964 | Celsi Warmer | Hadleigh Health Technologies | DWJ | Class II | 2025-06-20 |
| K251240 | Branchor X Balloon Guide Catheter | Asahi Intecc Co., Ltd. | QJP | Class II | 2025-06-20 |
| K251258 | MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula | Medtronic, Inc. | DWF | Class II | 2025-06-20 |
| K251560 | FUBUKI XF-R Neurovascular Long Sheath | Asahi Intecc Co., Ltd. | QJP | Class II | 2025-06-20 |
| K250492 | FlexiGo 3D Delivery Catheter | CenterPoint Systems, LLC | DQY | Class II | 2025-06-18 |
| K250219 | Dorado PTA Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | DQY | Class II | 2025-06-17 |
| K243003 | VitalSigns 1-Lead Holter (VSH101) | VitalSigns Technology Co., Ltd. | DXH | Class II | 2025-06-17 |
| K242863 | Bioptimal Bipolar Pacing Catheter | Bioptimal International Pte. , Ltd. | LDF | Class II | 2025-06-15 |
| K240795 | Withings ECG App | Withings | QDA | Class II | 2025-06-15 |
| K251189 | Aventus Thrombectomy System | Inquis Medical | QEW | Class II | 2025-06-13 |
| K251485 | Excipio LV Prime Thrombectomy Device | Contego Medical, Inc. | QEW | Class II | 2025-06-13 |
| K250075 | Medtronic Stedi Extra Support Guidewire | Medtronic, Inc. | DQX | Class II | 2025-06-13 |
| K250787 | Liberant Thrombectomy System | Medtronic, Ireland | QEW | Class II | 2025-06-11 |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | MWI | Class II | 2025-06-06 |
| K242750 | Central Station | Nihon Kohden Digital Health Solutions, LLC | MSX | Class II | 2025-06-05 |
| K250545 | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) | Surgical Instrument Service and Savings, Inc. | OWQ | Class II | 2025-06-05 |
| K250749 | PhysCade System | Physcade, Inc. | DQK | Class II | 2025-06-04 |
| K250259 | TeleRehab Aermos Cardiopulmonary Rehabilitation | The ScottCare Corporation | DRG | Class II | 2025-06-04 |
| K243948 | Raptor Aspiration Catheter; Balt Aspiration Tubing Set | Balt USA, LLC | NRY | Class II | 2025-06-03 |
| K250529 | Globe Introducer (601-01001) | Kardium, Inc. | DRA | Class II | 2025-06-03 |
| K250410 | GORE® Tri-Lobe Balloon Catheter | W. L. Gore & Associates, Inc. | DQY | Class II | 2025-06-02 |
| K251376 | LimFlow ARC | LimFlow, Inc. | PDU | Class II | 2025-05-31 |
| K250078 | Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) | Mindset Medical, Inc. | QME | Class II | 2025-05-30 |
| K251383 | Prestige Coil System (Prestige Packing Line Extension) | Balt USA, LLC | KRD | Class II | 2025-05-30 |
| K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) | Sorin Group Italia S.R.L. | DTR | Class II | 2025-05-30 |
| K251325 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | DRE | Class II | 2025-05-29 |
| DEN240048 | Spur Peripheral Retrievable Stent System | Reflow Medical, Inc. | SEU | Class II | 2025-05-29 |
| K250757 | Radius VSM and Accessories | Masimo Corporation | MHX | Class II | 2025-05-29 |
| K251344 | OptiMap System | Boston Scientific Corporation | DQK | Class II | 2025-05-28 |
| K243047 | Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing | Imperative Care, Inc. | NRY | Class II | 2025-05-28 |
| K250932 | DeepRhythmAI | Medicalgorithmics S.A. | DQK | Class II | 2025-05-27 |
| K251211 | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach | ABBOTT MEDICAL | OBJ | Class II | 2025-05-23 |
| K251044 | 93 NeuFlex Catheter | Piraeus Medical | QJP | Class II | 2025-05-23 |
| K243866 | InVision Precision Cardiac Amyloid | InVision Medical Technology Corporation | SDJ | Class II | 2025-05-21 |
| K251231 | ViewFlex X ICE Catheter, Sensor Enabled | ABBOTT MEDICAL | OBJ | Class II | 2025-05-20 |
| K250199 | VitalFlow Console | Medtronic, Inc. | QNR | Class II | 2025-05-20 |
| K243601 | Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set | Route 92 Medical, Inc. | NRY | Class II | 2025-05-19 |
| K243837 | iBSM | Iorbit Digital Technologies Private Limited | DRG | Class II | 2025-05-16 |
| K250971 | Embosphere Microspheres | Biosphere Medical, S.A. | KRD | Class II | 2025-05-16 |
| K242518 | Hypertension Prediction Index (HePI) Algorithm | Edwards Lifesciences, LLC | QAQ | Class II | 2025-05-15 |
| K250276 | Nitinol Enhanced Device (NED) | Embolization, Inc. | KRD | Class II | 2025-05-15 |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) | C.R. Bard, Inc. | LDF | Class II | 2025-05-15 |
| K250775 | Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy System | Imperative Care, Inc. | QEW | Class II | 2025-05-14 |
| K250421 | InThrill Thrombectomy System | Inari Medical, Inc. | QEW | Class II | 2025-05-12 |
| K250592 | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) | Northeast Scientific, Inc. | OWQ | Class II | 2025-05-12 |
| K243812 | Volta AF-Xplorer | Volta Medical | DQK | Class II | 2025-05-09 |
| K242392 | PATH BGC | Crossroads Neurovascular, Inc. | QJP | Class II | 2025-05-09 |
| K241086 | Avidhrt Sense SpO2 | Avidhrt, Inc. | DQA | Class II | 2025-05-09 |
| K251103 | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) | Philips Image Guided Therapy Corporation | OBJ | Class II | 2025-05-09 |
| K242962 | Telemetry Monitor 5500 Release 4.0 (867232) | Philips Medizin Systeme Böblingen GmbH | MHX | Class II | 2025-05-05 |
| K243603 | AeviceMD | Aevice Health Pte. , Ltd. | DSH | Class II | 2025-05-05 |
| K242986 | SpO2 Extension Cable | Beijing Rongrui-Century Science & Technology Co., Ltd. | DSA | Class II | 2025-05-02 |
| K243757 | Shockwave CS Guide Catheter | Shockwave Medical, Inc. | DQY | Class II | 2025-05-02 |
| K250161 | Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo | Shenzhen AOJ Medical Technology Co., Ltd. | DXN | Class II | 2025-05-02 |
| K242583 | AT-Patch (ATP-C130/ATP-C70) | Atsens Co., Ltd. | DSH | Class II | 2025-05-02 |
| K251007 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) | Circa Scientific, Inc. | DXF | Class II | 2025-05-01 |
| K251014 | APRO 45 Catheter | Alembic, LLC | DQY | Class II | 2025-05-01 |
| K251051 | AuST Steerable Sheath | CenterPoint Systems, LLC | DYB | Class II | 2025-04-30 |
| K244000 | Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+); | Shenzhen AOJ Medical Technology Co., Ltd. | DXN | Class II | 2025-04-30 |
| K243942 | Arctic Sun Stat Temperature Management System | Medivance, Inc. | DWJ | Class II | 2025-04-30 |
| K251015 | APRO 45 Catheter and Alembic Aspiration Tubing | Alembic, LLC | NRY | Class II | 2025-04-30 |
| K250962 | APRO 55 Intermediate Catheter | Alembic, LLC | DQY | Class II | 2025-04-29 |
| K250958 | APRO 55 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC | NRY | Class II | 2025-04-28 |
| K250426 | Amulet Steerable Delivery Sheath | ABBOTT MEDICAL | DQY | Class II | 2025-04-25 |
| K250909 | Prelude Wave Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | DYB | Class II | 2025-04-25 |
| K250723 | FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) | Cardio Flow Inc., | MCW | Class II | 2025-04-25 |
| K243954 | PeriCross Epicardial Access Kit | Circa Scientific, Inc. | DYB | Class II | 2025-04-24 |
| K250116 | Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B) | Shenzhen AOJ Medical Technology Co., Ltd. | DXN | Class II | 2025-04-24 |
| K243944 | Aperta NSE PTA Balloon Dilatation Catheter | Goodman Co., Ltd. | PNO | Class II | 2025-04-22 |
| K243383 | CHIKAI Nexus 014 | Asahi Intecc Co., Ltd. | MOF | Class II | 2025-04-21 |
| K242254 | D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | PNO | Class II | 2025-04-21 |
| K240775 | PeriBeam® Pericardial Membrane | Tamabio | DXZ | Class II | 2025-04-18 |
| K242129 | VitalRhythm | Vitalconnect, Inc. | DQK | Class II | 2025-04-17 |
| K242337 | FlowGuide (FG60F); GuidionShort (GS60F) | Imds Operations B.V. | DQY | Class II | 2025-04-17 |
| K243852 | Elfor-L | Elfi-Tech , Ltd. | DPW | Class II | 2025-04-14 |
| K250136 | Globalcare Blood Pressure Monitor (GUS610) | Globalcare Medical Technology Co., Ltd. | DXN | Class II | 2025-04-08 |
| K243691 | LiquID .051 LP Guide Catheter Extension | Seigla Medical, Inc. | DQY | Class II | 2025-04-04 |
| K243549 | JETi Hydrodynamic Thrombectomy System | ABBOTT MEDICAL | QEZ | Class II | 2025-04-04 |
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | Biotronik, Inc. | LIT | Class II | 2025-04-04 |
| K243236 | WHOOP ECG (electrocardiogram) Feature (1.0) | Whoop., Inc. | QDA | Class II | 2025-04-04 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.