Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 53
- Latest Decision
- 2022-02-17
Clearances · page 18 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K220137 | Lunderquist Extra Stiff Wire Guide | William Cook Europe Aps | DQX | Class II | 2022-02-17 |
| K212977 | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands | Cordis Corporation | DQO | Class II | 2022-02-17 |
| K203793 | RithmID-SD Steerable Diagnostic Electrophysiology Catheter | Synaptic Medical Corporation | DRF | Class II | 2022-02-14 |
| K211610 | Fogarty Occlusion Catheter | Edwards Lifesciences, LLC | MJN | Class II | 2022-02-14 |
| K211400 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | DQA | Class II | 2022-02-11 |
| K212622 | Zyter RPM | Zyter, Inc. | MSX | Class II | 2022-02-11 |
| K202926 | Micro Catheter | Shanghai Heartcare Medical Technology Co., Ltd. | QJP | Class II | 2022-02-10 |
| K211327 | Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters | CathRx, Ltd. | DRF | Class II | 2022-02-10 |
| K212211 | Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter | Vascular Solutions, LLC | DQY | Class II | 2022-02-09 |
| K212167 | R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire | Vascular Solutions, LLC | DQX | Class II | 2022-02-09 |
| K213313 | Veinoflow SCD (Model: LBTK-M-I 5006) | Dalian Labtek Science & Development Co., Ltd. | JOW | Class II | 2022-02-09 |
| K211530 | PathBuilder Steerable Introducer | Shanghai Microport EP Medtech Co., Ltd. | DYB | Class II | 2022-02-08 |
| K220047 | AcQCross Qx Integrated Transseptal Dilator/Needle | Acutus Medical, Inc. | DYB | Class II | 2022-02-08 |
| K211822 | LifePath Remote Patient Monitoring Platform | Elastic Care Incorporated | DRG | Class II | 2022-02-03 |
| K203088 | Infinity Acute Care System (IACS) Monitoring System | Draeger Medical Systems, Inc. | MHX | Class II | 2022-02-01 |
| K213565 | JETi AIO Peripheral Thrombectomy System | Walk Vascular, LLC | QEZ | Class II | 2022-02-01 |
| K214106 | QuikPass Catheter | Traverse Vascular, Inc. | DQY | Class II | 2022-01-28 |
| K212341 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U | Qura S.R.L | DTZ | Class II | 2022-01-28 |
| K213771 | Merlin Aspiration System | Mivi Neurovascular, Inc. | DXE | Class II | 2022-01-27 |
| K212312 | RA-T59 Wrist blood pressure monitor | Lotusnine Medical Limited | DXN | Class II | 2022-01-27 |
| K211941 | 9Line | Energetic Designs, Inc. | DSA | Class II | 2022-01-27 |
| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger | Remington Medical, Inc. | DPW | Class II | 2022-01-27 |
| K211219 | LASSOSTAR NAV Circular Mapping Catheter | Biosense Webster, Inc. | DRF | Class II | 2022-01-26 |
| K211532 | Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33 | Yibin Junxin Electronics Technology Co., Ltd. | DXN | Class II | 2022-01-19 |
| K211709 | Biotres | Biotricity | MWJ | Class II | 2022-01-19 |
| K213593 | OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD | Boston Scientific Corporation | OBJ | Class II | 2022-01-14 |
| K201057 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | QHW | Class II | 2022-01-14 |
| K211632 | Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104) | Shenzhen Narig Bio-Medical Technology Co., Ltd. | DQA | Class II | 2022-01-14 |
| K213335 | Capsule Surveillance System | Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. | MWI | Class II | 2022-01-14 |
| K213915 | BIB Stent Placement Catheter | NuMED, Inc. | NVM | Class II | 2022-01-12 |
| K212877 | Arm Blood Pressure Monitor | Alicn Medical Shenzhen, Inc. | DXN | Class II | 2022-01-12 |
| K202094 | Cardiovascular Suite 4.2.1 | Quipu S.R.L | DQK | Class II | 2022-01-11 |
| K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger | Qura S.R.L | DTR | Class II | 2022-01-10 |
| K212152 | Prelude IDeal 9F Hydrophilic Sheath Introducer | Merit Medical Systems | DYB | Class II | 2022-01-07 |
| K211349 | Selebrek PTCA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | LOX | Class II | 2022-01-07 |
| K211110 | Agile Devices Angler Steerable, Deflectable Microcatheter | Agile Devices, Inc. | KRA | Class II | 2022-01-07 |
| K212468 | Tigereye CTO-Crossing Catheter | Avinger, Inc. | PDU | Class II | 2022-01-06 |
| K212115 | Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor | Joytech Healthcare Co. , Ltd. | DXN | Class II | 2022-01-05 |
| K210305 | Pulse Oximeter | Dongguan Lingxin Technologies Co., Ltd. | DQA | Class II | 2021-12-22 |
| DEN210024 | CavaClear Laser Sheath | Spectranetics, Inc. | QRJ | Class II | 2021-12-21 |
| K211078 | Progreat Lambda | Terumo Clinical Supply Co., Ltd. | DQO | Class II | 2021-12-21 |
| K210331 | CardiaMend Pericardial and Epicardial Reconstruction Matrix | Helios Cardio, Inc. | PSQ | Class II | 2021-12-21 |
| K212776 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | Innovative Health, LLC | NLG | Class II | 2021-12-20 |
| K213531 | TR BAND Radial Compression Device | Terumo Medical Corporation | DXC | Class II | 2021-12-20 |
| K213031 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console | Zoll Circulation, Inc. | NCX | Class II | 2021-12-20 |
| K212340 | EMBOGUARD Balloon Guide Catheter | Neuravi Limited | QJP | Class II | 2021-12-17 |
| K203424 | Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 | Qura S.R.L | DTZ | Class II | 2021-12-17 |
| K212402 | MIVI Q Distal Access Catheter | Mivi Neuroscience, Inc. | QJP | Class II | 2021-12-16 |
| K212351 | Revolution Peripheral Atherectomy System | Rex Medical, L.P. | MCW | Class II | 2021-12-15 |
| K212817 | Merit Siege Vascular Plug | Merit Medical System, Inc. | KRD | Class II | 2021-12-15 |
| K213728 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | PNO | Class II | 2021-12-15 |
| K213631 | Chocolate PTA Balloon Catheter | Medtronic, Inc. | LIT | Class II | 2021-12-15 |
| K213422 | EkoSonic Endovascular Device, EKOS+ Endovascular Device | Boston Scientific Corporation | QEY | Class II | 2021-12-14 |
| K213638 | Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) | Argon Medical Devices | DYB | Class II | 2021-12-10 |
| K202510 | AMG PMP Infant | Eurosets S.R.L | DTZ | Class II | 2021-12-10 |
| K203723 | Branchor Balloon Guide Catheter | Asahi Intecc Co., Ltd. | QJP | Class II | 2021-12-10 |
| K201764 | Infinity Acute Care System (IACS) Monitoring Solution | Draeger Medical Systems, Inc. | MHX | Class II | 2021-12-09 |
| K211949 | AirStrip ONE Web Client with Alarm Communication Management (ACM) | Airstrip Technologies, Inc. | MSX | Class II | 2021-12-09 |
| K211898 | ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 | Asahi Intecc Co., Ltd. | DQX | Class II | 2021-12-08 |
| K211561 | INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) | Covidien, LLC | MUD | Class II | 2021-12-05 |
| K212219 | AHI System | Fifth Eye, Inc. | QNV | Class II | 2021-12-03 |
| K211668 | KardiaMobile Card | AliveCor, Inc. | DXH | Class II | 2021-11-30 |
| K211594 | Trevo Trak 21 Microcatheter | Stryker Neurovascular | QJP | Class II | 2021-11-26 |
| K210009 | Guiding Catheter | CenterPoint Systems, LLC | DQY | Class II | 2021-11-24 |
| K212529 | Hypotension Decision Assist Model HDA-OR2 | Directed Systems, Ltd. | DXG | Class II | 2021-11-23 |
| K211651 | Eclipse PRO | Spacelabs Healthcare, Ltd. | MWJ | Class II | 2021-11-22 |
| K211741 | Pre-Formed Extra Support Guidewire | Lake Region Medical | DQX | Class II | 2021-11-22 |
| K213451 | Spartan MC 0165 | Spartan Micro | QJP | Class II | 2021-11-22 |
| K211080 | EkoSonic Endovascular Device | Boston Scientific | QEY | Class II | 2021-11-19 |
| K211937 | SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System | Jiangsu Synecoun Medical Technology Co., Ltd. | JOW | Class II | 2021-11-18 |
| K212112 | Cardiologs Holter Platform | Cardiologs Technologies | DPS | Class II | 2021-11-18 |
| K200091 | Capiox iCP Centrifugal Pump | Terumo Cardiovascular Systems Corporation | KFM | Class II | 2021-11-18 |
| K211662 | Reprocessed IntellaMap Orion High Resolution Mapping Catheter | Innovative Health, LLC | NLG | Class II | 2021-11-18 |
| K211697 | Esperance Aspiration Catheter System | Wallaby Medical | NRY | Class II | 2021-11-16 |
| K212047 | Pantheris System | Avinger, Inc. | MCW | Class II | 2021-11-16 |
| K212731 | Circul8 Pro | Ortho8, Inc. | JOW | Class II | 2021-11-15 |
| K211754 | Vital Signs Monitor | Beijing Choice Electronic Technology Co., Ltd. | MWI | Class II | 2021-11-15 |
| DEN210006 | Hemolung Respiratory Assist System | Alung Technologies, Inc. | QOH | Class II | 2021-11-13 |
| K213364 | EnSite X EP System | ABBOTT MEDICAL | DQK | Class II | 2021-11-11 |
| K212003 | ESSENZ Patient Monitor | Livanova Deutschland, GmbH | DXJ | Class II | 2021-11-10 |
| K203746 | Venen-trainer (Model: FM150, SFM90) | Shenzhen Pango Electronic Co., Ltd. | JOW | Class II | 2021-11-10 |
| K212013 | eKuore Pro 4T - REF EP0098 | Chip Ideas Electronics S.L. | DQD | Class II | 2021-11-10 |
| K211546 | Vektor Computational ECG Mapping System (vMap) | Vektor Medical, Inc. | DQK | Class II | 2021-11-09 |
| K211289 | RMU-2000 Automated Chest Compression System | Defibtech, LLC | DRM | Class II | 2021-11-09 |
| K203067 | Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F | Qura S.R.L | DWF | Class II | 2021-11-08 |
| K211288 | Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B | Microlife Intellectual Property GmbH | DXN | Class II | 2021-11-04 |
| K201320 | Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor | Qura S.R.L | KFM | Class II | 2021-11-03 |
| K212199 | ASAP Aspiration Catheter, ASAPLP Aspiration Catheter | Merit Medical Systems, Inc. | QEZ | Class II | 2021-11-03 |
| K210543 | IM007 | Implicity, Inc. | DQK | Class II | 2021-11-03 |
| K212171 | Electronic Blood Pressure Monitor | Dongguan Kangweile Electronic Technology Co., Ltd. | DXN | Class II | 2021-11-01 |
| K213264 | CARTO 3 EP Navigation System Version 7.2 | Biosense Webster, Inc. | DQK | Class II | 2021-10-29 |
| K213166 | Thrombuster II Aspiration Catheter | Kaneka Medical America, LLC | QEZ | Class II | 2021-10-26 |
| K212516 | IRNF App | Apple, Inc. | QDB | Class II | 2021-10-22 |
| K212061 | EnSite X EP System | Abbott | DQK | Class II | 2021-10-22 |
| K211407 | Belun Ring BLR-100X | Belun Technology Company Limited | DQA | Class II | 2021-10-21 |
| K210322 | XO Cross Support Catheter | Transit Scientific, LLC | DQY | Class II | 2021-10-21 |
| K212490 | AVVIGO Guidance System II | Boston Scientific Corporation | DQK | Class II | 2021-10-20 |
| K211564 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Boon Medical Supply Co., Ltd. | DXT | Class II | 2021-10-19 |
| K210204 | Capsule Vitals Plus Patient Monitoring System | Capsule Technologie Sas | MWI | Class II | 2021-10-19 |
| K210911 | WOLF Thrombectomy System, 14F | Devoro Medical, Inc. | QEW | Class II | 2021-10-19 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.