Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 54
- Latest Decision
- 2023-07-26
Clearances · page 13 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K231038 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LLC | QNL | Class II | 2023-07-26 |
| K222994 | Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B | Shenzhen AOJ Medical Technology Co., Ltd. | DXN | Class II | 2023-07-26 |
| K231621 | Reprocessed ViewFlex Xtra ICE Catheter (D087031) | Stryker Sustainability Solutions | OWQ | Class II | 2023-07-25 |
| K231848 | Triever20 Curve (21-201) | Inari Medical, Inc. | QEW | Class II | 2023-07-21 |
| K231173 | Irregular Rhythm Notification Feature (IRNF) | Apple, Inc. | QDB | Class II | 2023-07-21 |
| K223189 | Firefighter NC Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | LOX | Class II | 2023-07-21 |
| K230377 | CROSSLEAD Penetration Peripheral Guide Wire | Asahi Intecc Co., Ltd. | DQX | Class II | 2023-07-20 |
| K211143 | Pulse Oximeter | Shenzhen Brav Electronic Technologies Co., Ltd. | DQA | Class II | 2023-07-17 |
| K223791 | TalWire | Embrace Medical , Ltd. | DQX | Class II | 2023-07-14 |
| K223728 | Micro Rx | Imds Operations B.V. | DQY | Class II | 2023-07-13 |
| K231035 | FusedCO Algorithm | Edwards Lifesciences, LLC | DQK | Class II | 2023-07-12 |
| K230823 | AusculThing ACC | Ausculthing OY | DQD | Class II | 2023-07-12 |
| K231091 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | 2023-07-10 |
| K231412 | CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) | Biosense Webster, Inc. | DYB | Class II | 2023-07-10 |
| K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID | Biosense Webster, Inc. | MTD | Class II | 2023-07-10 |
| K223578 | T3 Platform software | Etiometry, Inc. | PPW | Class II | 2023-07-07 |
| K223382 | AeviceMD | Aevice Health Pte. , Ltd. | DSH | Class II | 2023-07-07 |
| K221056 | ARGUS PB-3000 | Schiller AG | MHX | Class II | 2023-07-06 |
| K231279 | Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm | Ablative Solutions, Inc. | KRA | Class II | 2023-07-05 |
| K231653 | BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter | Thrombolex, Inc. | QEY | Class II | 2023-07-03 |
| K231588 | ViewFlex Eco Reprocessed ICE Catheter | ABBOTT MEDICAL | OWQ | Class II | 2023-06-30 |
| K231596 | IOB Temperature Management System | Iob Medical, Inc. | DWJ | Class II | 2023-06-30 |
| K223374 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | DXN | Class II | 2023-06-30 |
| K221294 | preCARDIA Occlusion System | Abiomed, Inc. | MJN | Class II | 2023-06-30 |
| K230156 | 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter | Medtronic Vascular | DQY | Class II | 2023-06-30 |
| K230176 | Upper Arm Blood Pressure Monitor | Shenzhen Yolanda Technology Co., Ltd. | DXN | Class II | 2023-06-29 |
| K230374 | Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®) | Dongguan TT Medical, Inc. | LOX | Class II | 2023-06-29 |
| K230866 | HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC | DWJ | Class II | 2023-06-29 |
| K230859 | Aneroid Sphygmomanometer | Wenzhou Kangshun Medical Devices Co.,Ltd | DXQ | Class II | 2023-06-28 |
| K230075 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K | Microlife Intellectual Property GmbH | DXN | Class II | 2023-06-28 |
| K230706 | EMBOLD Soft Detachable Coil System | Boston Scientific Corporation | KRD | Class II | 2023-06-27 |
| K231505 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | DSY | Class II | 2023-06-23 |
| K223013 | AccurECG Analysis System | Accurkardia, Inc. | DPS | Class II | 2023-06-23 |
| K230322 | SelectFlex Neurovascular Access System Family | Q'Apel Medical, Inc. | QJP | Class II | 2023-06-22 |
| K230309 | Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1) | Centerline Biomedical, Inc. | DQK | Class II | 2023-06-21 |
| K222658 | Accurate 24 Non-invasive blood pressure monitor | Accurate Meditech, Inc. | DXN | Class II | 2023-06-21 |
| K231148 | ScleroSafe 150 mm, ScleroSafe 350 mm | Vvt Medical , Ltd. | KRA | Class II | 2023-06-20 |
| K223217 | Zynex Monitoring System, Model CM-1600 | Zynex Medical, Inc. | DSB | Class II | 2023-06-16 |
| K222597 | BabySat 3 | Owlet Babycare, Inc. | DQA | Class II | 2023-06-16 |
| K230386 | SpassageQ | Spass, Inc. | PLB | Class II | 2023-06-15 |
| K223291 | Electronic Blood Pressure Monitor | Shenzhen Pango Medical Electronics Co., Ltd. | DXN | Class II | 2023-06-14 |
| K231022 | Pounce Thrombectomy System | Surmodics,Inc. | QEW | Class II | 2023-06-12 |
| K223361 | BMR 1900 PHISIO | Sorin Group Italia S.R.L. | DTN | Class II | 2023-06-10 |
| K230709 | Auryon Atherectomy System | Eximo Medical, Ltd. | MCW | Class II | 2023-06-09 |
| K223865 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor | Edwards Lifesciences, LLC | DQK | Class II | 2023-06-09 |
| K230057 | Acumen Hypotension Prediction Index (HPI) Algorithm | Edwards Lifesciences, LLC | QAQ | Class II | 2023-06-08 |
| K223918 | AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub | Philips Medical Systems Nederland B.V. | DQK | Class II | 2023-06-08 |
| K230008 | Ablamap® System | Ablacon, Inc. | DQK | Class II | 2023-06-08 |
| K230005 | Pantheris LV Atherectomy Catheter | Avinger, Inc. | MCW | Class II | 2023-06-06 |
| K230584 | Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter | Vein 360, LLC | OWQ | Class II | 2023-06-06 |
| K220117 | ARC Intensive Care Information System (ARC System) | Ordinatrum Solutions | MWI | Class II | 2023-06-06 |
| K231311 | CPS Direct Universal slittable outer guide catheter (DS2C029) | ABBOTT MEDICAL | DQY | Class II | 2023-06-02 |
| K230214 | Huma RPM (RPM) | Medopad, Inc. | MWI | Class II | 2023-06-02 |
| K231293 | Drakon and Sequre® Microcatheters | Accurate Medical Therapeutics | DQO | Class II | 2023-06-01 |
| K223498 | Radius VSM and Accessories | Masimo Corporation | MHX | Class II | 2023-06-01 |
| K223929 | Laguna Clot Retriever System and Malibu Aspiration Catheter System (Laguna Thrombectomy System) | Innova Vascular, Inc. | QEW | Class II | 2023-06-01 |
| K221067 | Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter | Surgical Instrument Service and Savings, Inc. | NLH | Class II | 2023-05-31 |
| K230030 | Excipio SV Aspiration Catheter and Tubing | Contego Medical, Inc. | QEW | Class II | 2023-05-30 |
| K223809 | PrecisionTAVI (v1.1) | Dasi Simulations | QQI | Class II | 2023-05-30 |
| K230571 | RFP-100A Connector Cable (Single Use) | Baylis Medical Technologies, Inc. | DSA | Class II | 2023-05-30 |
| K230263 | Finesse Injectable PTA Balloon Dilatation Catheter | Summa Therapeutics, LLC | LIT | Class II | 2023-05-26 |
| K223651 | Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences, LLC | MUD | Class II | 2023-05-26 |
| K230111 | CORE 500 Digital Stethoscope | Eko Devices, Inc. | DQD | Class II | 2023-05-26 |
| K230679 | WellsForm Tricuspid Annuloplasty Band (WF) | Genesee Biomedical, Inc. | KRH | Class II | 2023-05-26 |
| K231176 | Stingray LP Catheter | Boston Scientific | DQY | Class II | 2023-05-25 |
| K230273 | Saranas Early Bird Bleed Monitoring System | Saranas, Inc. | QFJ | Class II | 2023-05-25 |
| K230631 | Kodiak Dual Port Coaxial Introducer Kit | Argon Medical Devices | DYB | Class II | 2023-05-22 |
| K231168 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support | Imperative Care, Inc. | QJP | Class II | 2023-05-22 |
| K222979 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W | Microlife Intellectual Property GmbH | DXN | Class II | 2023-05-19 |
| K230375 | BIOMONITOR IV | Biotronik, Inc. | MXD | Class II | 2023-05-19 |
| K220842 | Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors | Qura S.R.L | KFM | Class II | 2023-05-19 |
| K230769 | PrevisEA Device | Entac Medical, Inc. | DQD | Class II | 2023-05-19 |
| K230453 | OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter | Boston Scientific Corporation | OBJ | Class II | 2023-05-18 |
| K230286 | Assert-IQ Insertable Cardiac Monitor | ABBOTT MEDICAL | MXC | Class II | 2023-05-17 |
| K222254 | Gunther Tulip Vena Cava Filter Retrieval Set | Cook Incorporated | MMX | Class II | 2023-05-16 |
| K220526 | HD+12, HD+15 | Cardioline S.P.A | DRG | Class II | 2023-05-15 |
| K230637 | Wattson temporary pacing guidewire (2250) | Vascular Solutions, LLC | DQX | Class II | 2023-05-05 |
| K222926 | Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683 | Shenzhen Yuezhongxing Technology Co., Ltd. | DXN | Class II | 2023-05-05 |
| K230960 | DLP Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | DWF | Class II | 2023-05-04 |
| K230530 | SOZO Pro | ImpediMed Limited | OBH | Class II | 2023-05-04 |
| K230531 | SOZO Pro | ImpediMed Limited | QJB | Class II | 2023-05-04 |
| K221798 | Finger Pulse Oximeter, Model: X1906P | Shenzhen Changkun Technology Co., Ltd. | DQA | Class II | 2023-05-04 |
| K223843 | FloPatch FP120 | Flosonics Medical | DPW | Class II | 2023-05-03 |
| K230934 | ViewFlex Eco Reprocessed ICE Catheter | ABBOTT MEDICAL | OWQ | Class II | 2023-05-03 |
| K230912 | Artix BG | Inari Medical | QEW | Class II | 2023-05-02 |
| K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | Samsung Electronics Co., Ltd. | QDA | Class II | 2023-05-02 |
| K230606 | AcQMap® High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | 2023-05-02 |
| K230957 | TriSalus TriNav® LV Infusion System | Trisalus Life Sciences | KRA | Class II | 2023-05-02 |
| K221390 | BNLE Access Guidewire | Biomerics Nle | DQX | Class II | 2023-04-28 |
| K223210 | ClotTriever XL Catheter | Inari Medical, Inc. | QEW | Class II | 2023-04-27 |
| K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) | MicroVention, Inc. | NTE | Class II | 2023-04-27 |
| K230553 | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application | Medtronic, Inc. | MXD | Class II | 2023-04-26 |
| K223139 | Wallaby 017 Micro Catheter | Wallaby Medical | KRA | Class II | 2023-04-25 |
| K230594 | Tigereye ST CTO-Crossing Catheter | Avinger, Inc. | PDU | Class II | 2023-04-25 |
| K230503 | Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable | Boston Scientific | DRF | Class II | 2023-04-25 |
| K222690 | SmartGUIDE deflectable hydrophilic guidewire | Artiria Medical SA | MOF | Class II | 2023-04-24 |
| K222330 | The Heart Seat | Casana Care, Inc. | MWI | Class II | 2023-04-24 |
| K230704 | RAIN Sheath Tibial Pedal Introducer | Cordis US Corp | DYB | Class II | 2023-04-24 |
| K221742 | CONNEQT PULSE | Atcor Medical | DXN | Class II | 2023-04-21 |
| K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 | Thrombolex, Inc. | QEY | Class II | 2023-04-20 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.