Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 49
- Latest Decision
- 2022-05-31
Clearances · page 17 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K220113 | Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) | Shenzhen Finicare Co., Ltd. | DXN | Class II | 2022-05-31 |
| K213065 | Distal Access Catheter | Guangzhou Easycess Medical Co.,Ltd | QJP | Class II | 2022-05-31 |
| K212838 | Benchmark Intracranial Access System | Penumbra, Inc. | QJP | Class II | 2022-05-27 |
| K212268 | FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT | FMD Co., Ltd. | DQX | Class II | 2022-05-27 |
| K220557 | MoistureMeterD Compact, LymphScanner | Delfin Technologies, Ltd. | OBH | Class II | 2022-05-27 |
| K211779 | ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. | Chip Ideas Electronics S.L. | DQD | Class II | 2022-05-26 |
| K210655 | Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | Innovative Health, LLC | OWQ | Class II | 2022-05-25 |
| K220350 | KardiaMobile 6L | AliveCor, Inc. | DXH | Class II | 2022-05-25 |
| K220470 | Smart Wireless Stethoscope | Shanghai Hulu Devices Co., Ltd. | DQD | Class II | 2022-05-23 |
| K213402 | Triever24, Triever20 | Inari Medical | QEW | Class II | 2022-05-23 |
| K212988 | ONO Retrieval Device | Onocor Vascular, LLC | MMX | Class II | 2022-05-23 |
| K212752 | Med-link Pulse Oximeter | Shenzhen Med-Link Electronics Tech Co., Ltd. | DQA | Class II | 2022-05-20 |
| K213540 | Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set | Qura S.R.L | DWF | Class II | 2022-05-20 |
| K212416 | WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203 | Wenzhou Xikang Medical Instruments Co., Ltd. | DXQ | Class II | 2022-05-18 |
| K210548 | Medline Integrated Arterial Catheter | Centurion Medical Products | DQX | Class II | 2022-05-17 |
| K220807 | Imperative Care Radial 088 Access System | Imperative Care, Inc. | QJP | Class II | 2022-05-17 |
| K220414 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | DYB | Class II | 2022-05-09 |
| K214072 | Masimo O3 Regional Oximeter System | Masimo Corporation | MUD | Class II | 2022-05-06 |
| K212657 | Quantum Heater-Cooler | Spectrum Medical , Ltd. | DWC | Class II | 2022-05-06 |
| K212555 | Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC | Covidien, LLC | DQA | Class II | 2022-05-06 |
| K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger | Qura S.R.L | DTR | Class II | 2022-05-06 |
| K221044 | AcQGuide® VUE Steerable Sheath | Acutus Medical, Inc. | DRA | Class II | 2022-05-05 |
| K220691 | LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension | Seigla Medical, Inc. | DQY | Class II | 2022-05-05 |
| K220716 | Spartan SC 069 | Spartan Micro, Inc. | DQY | Class II | 2022-05-05 |
| K221057 | Viatrac 14 Plus Peripheral Dilatation Catheter | Abbott Vascular | LIT | Class II | 2022-05-05 |
| K212588 | Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter | C.R. Bard, Inc. | DQY | Class II | 2022-05-04 |
| K201302 | LiveOne | Livemetric (Medical) S.A. | DXN | Class II | 2022-05-04 |
| K220704 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | PNO | Class II | 2022-05-04 |
| K221010 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | MUD | Class II | 2022-05-03 |
| K220306 | ECGenius System | Cath Vision Aps | DQK | Class II | 2022-05-03 |
| K220243 | Ultiri Measurement System | ABBOTT MEDICAL | DQK | Class II | 2022-04-30 |
| K220383 | LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) | Okami Medical | KRD | Class II | 2022-04-29 |
| K220899 | Oxehealth Vital Signs | Oxehealth Limited | QME | Class II | 2022-04-29 |
| K220604 | EXTesia Introducer Sheath Set | Curatia Medical Co. | DYB | Class II | 2022-04-27 |
| K220568 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series | Cardiovascualr Systems, Inc. | MCW | Class II | 2022-04-27 |
| K220893 | Strados Remote Electronic Stethoscope Platform (RESP) | Strados Labs, Inc. | DSH | Class II | 2022-04-27 |
| K212662 | AliveCor QT Service | AliveCor, Inc. | DQK | Class II | 2022-04-26 |
| K213861 | CER-S | Cardiocalm Srl | DQK | Class II | 2022-04-25 |
| K221041 | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System | Shockwave Medical, Inc. | PPN | Class II | 2022-04-25 |
| K213730 | MESI mTABLET TBI diagnostic system, MESI mTABLET TBI | Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. | JOM | Class II | 2022-04-21 |
| K220866 | EKOS+ Endovascular Device | Boston Scientific | QEY | Class II | 2022-04-20 |
| K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2) | Synovis Micro Companies Alliance, Inc. | DPW | Class II | 2022-04-20 |
| K220075 | Spartan Center Wire | Spartan Micro, Inc. | DQX | Class II | 2022-04-19 |
| K214053 | Amputee Garment for use with Lympha Press Optimal Plus | Mego Afek AC , Ltd. | JOW | Class II | 2022-04-14 |
| K212163 | Coala Heart Monitor | Coala Life AB | DPS | Class II | 2022-04-14 |
| K203842 | Bendit21 Microcatheter | Bend IT Technologies, Ltd. | QJP | Class II | 2022-04-13 |
| K220773 | Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P) | Medtronic Vascular | MAV | Class II | 2022-04-13 |
| K213363 | CARESCAPE B450, E-musb | GE Healthcare Finland Oy | MHX | Class II | 2022-04-13 |
| K213181 | CARESCAPE B650, E-musb | GE Healthcare Finland Oy | MHX | Class II | 2022-04-13 |
| K213336 | Carescape B850, E-musb | GE Healthcare Finland Oy | MHX | Class II | 2022-04-13 |
| K214025 | PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter | Medos International SARL | KRA | Class II | 2022-04-12 |
| K213398 | EMBOLD Fibered Detachable Coil System | Boston Scientific Corporation | KRD | Class II | 2022-04-12 |
| K213234 | CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201 | Ge Medical Systems Information Technologies, Inc. | MHX | Class II | 2022-04-12 |
| K212719 | Micro Catheter and Guidewire System | Suzhou Hengrui Hongyuan Medical Co., Ltd. | KRA | Class II | 2022-04-11 |
| K214107 | XO CROSS CORONARY Support Catheter | Transit Scientific, LLC | DQY | Class II | 2022-04-11 |
| K220699 | Prestige Coil System | Bait USA, LLC | KRD | Class II | 2022-04-08 |
| K212372 | Fitbit Irregular Rhythm Notifications | Fitbit, Inc. | QDB | Class II | 2022-04-08 |
| K212278 | Electrocardiograph | Edan Instruments, Inc. | DPS | Class II | 2022-04-07 |
| K220654 | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire | Cordis Corporation | NTE | Class II | 2022-04-06 |
| K214114 | Prodigy Thrombectomy System | Truvic Medical, Inc. | QEW | Class II | 2022-04-06 |
| K213388 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | AngioDynamics, Inc. | QEZ | Class II | 2022-04-04 |
| K213657 | DEEPVESSEL FFR | Keyamed Na, Inc. | PJA | Class II | 2022-04-01 |
| K213494 | Aveir Retrieval Catheter | ABBOTT MEDICAL | MMX | Class II | 2022-04-01 |
| K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | Ge Medical Systems Information Technologies, Inc. | MHX | Class II | 2022-04-01 |
| K212392 | Intri24 Sheath | Inari Medical, Inc. | DYB | Class II | 2022-04-01 |
| K211120 | ERIC Retrieval Device | MicroVention, Inc. | NRY | Class II | 2022-03-31 |
| K212894 | PhasTIPP | LeMaitre Vascular, Inc. | DWQ | Class II | 2022-03-31 |
| K213699 | CareTaker Monitor App | Caretaker Medical, LLC | DXN | Class II | 2022-03-30 |
| K220600 | Artix Thrombectomy Device | Inari Medical | QEW | Class II | 2022-03-25 |
| K220362 | LE-12CH | Caf Medical Solutions, Inc. | DPS | Class II | 2022-03-25 |
| K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies , Ltd. | DQA | Class II | 2022-03-25 |
| K213589 | FUBUKI XF Neurovascular Long Sheath | Asahi Intecc Co., Ltd. | QJP | Class II | 2022-03-24 |
| K220196 | Steth IO Spot | Stratoscientific | DQD | Class II | 2022-03-24 |
| K213492 | Dib UltraNav Transseptal Catheter System | Dib Ultranav Medical, LLC | DYB | Class II | 2022-03-24 |
| K220629 | Emerge Monorail PTCA Dilatation Catheter | Boston Scientific | LOX | Class II | 2022-03-24 |
| K211365 | Alio Medical Remote Monitoring System | Graftworx, Inc. Dba Alio | DRG | Class II | 2022-03-24 |
| K212625 | PathBuilder Transseptal Needle | Shanghai Microport EP Medtech Co., Ltd. | DRC | Class II | 2022-03-23 |
| K212626 | PathBuilder Transseptal Guiding Introducer | Shanghai Microport EP Medtech Co., Ltd. | DYB | Class II | 2022-03-23 |
| K220501 | Pounce Thrombectomy System | Surmodics,Inc. | QEW | Class II | 2022-03-23 |
| K213200 | Solus Gold Embolization Device | Artio Medical, Inc. | KRD | Class II | 2022-03-21 |
| K211438 | OPTRELL Mapping Catheter with TRUEref Technology | Biosense Webster, Inc. | MTD | Class II | 2022-03-18 |
| K213834 | Cardio Flow Peripheral Guide Wire | Cardio Flow Inc., | DQX | Class II | 2022-03-18 |
| K212709 | VoqX Electronic Stethoscope | Sanolla , Ltd. | DQD | Class II | 2022-03-15 |
| K213314 | CerusEndo Microcatheter (027) | Cerus Endovascular, Inc. | QJP | Class II | 2022-03-15 |
| K212393 | OPN NC PTCA Dilatation Catheter | Sis Medical AG | LOX | Class II | 2022-03-14 |
| K212165 | Reprocessed Carto Vizigo Bi-Directional Guiding Sheath | Innovative Health, LLC | PNE | Class II | 2022-03-10 |
| K220340 | Amplatzer Steerable Delivery Sheath | ABBOTT MEDICAL | DQY | Class II | 2022-03-09 |
| K211138 | Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I) | Stryker Sustainability Solutions | NLF | Class II | 2022-03-08 |
| K211140 | Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 | Stryker Sustainability Solutions | DQA | Class II | 2022-03-08 |
| K211900 | Patient Information Center iX | Philips Medizin Systeme Böblingen GmbH | MHX | Class II | 2022-03-04 |
| K220109 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | MCW | Class II | 2022-03-01 |
| K211802 | GoBack Crossing Catheter | Upstream Peripheral Technologies, Ltd. | PDU | Class II | 2022-03-01 |
| K213189 | Wrist-type Fully Automatic Digital Blood Pressure Monitor | Joytech Healthcare Co. , Ltd. | DXN | Class II | 2022-03-01 |
| K212057 | Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS | Artventive Medical Group, Inc. | KRD | Class II | 2022-03-01 |
| K212300 | Pulse Oximeter | Shenzhen Mericonn Technology Co., Ltd. | DQA | Class II | 2022-02-25 |
| K214066 | FEops HEARTguide | Feops NV | QQI | Class II | 2022-02-25 |
| K211798 | Cleaner Plus Thrombectomy System | Argon Medical Devices, Inc. | QEW | Class II | 2022-02-24 |
| K213503 | Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E | Shenzhen AOJ Medical Technology Co., Ltd. | DXN | Class II | 2022-02-18 |
| K211679 | Xtractor device | Xcardia Innovation , Ltd. | DRE | Class II | 2022-02-17 |
| K213972 | Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX | Ge Healthcare Information Technologies, Inc. | DQK | Class II | 2022-02-17 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.