Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 48
- Latest Decision
- 2022-12-30
Clearances · page 15 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K222010 | Biobeat Platform-2 and BB-613WP Patch | Biobeat Technologies , Ltd. | DQA | Class II | 2022-12-30 |
| K211619 | Multi-Parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | MHX | Class II | 2022-12-29 |
| K211557 | EndoPATx | Itamar Medical , Ltd. | DQK | Class II | 2022-12-29 |
| K221669 | IOB Warming Blankets | Iob Medical, Inc. | DWJ | Class II | 2022-12-27 |
| K223094 | EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade; EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software License | ABBOTT MEDICAL | DQK | Class II | 2022-12-27 |
| K222216 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | DXO | Class II | 2022-12-22 |
| K221902 | LimFlow Vector | LimFlow, Inc. | MGZ | Class II | 2022-12-21 |
| K222538 | NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter | Sino Medical Sciences Technology, Inc. | LOX | Class II | 2022-12-21 |
| K223050 | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) | MicroVention, Inc. | KRD | Class II | 2022-12-21 |
| K222586 | Mural Clinical Viewer | Ge Medical Systems Information Technologies, Inc. | MHX | Class II | 2022-12-21 |
| K221904 | EK12 V2 Algorithm | Ge Medical Systems Information Technologies, Inc. | MHX | Class II | 2022-12-20 |
| K222358 | Indigo Aspiration System - Lightning Flash | Penumbra, Inc. | QEW | Class II | 2022-12-20 |
| K222808 | Penumbra System (Reperfusion Catheter RED 43) | Penumbra, Inc. | NRY | Class II | 2022-12-20 |
| K222217 | ViewFlex Xtra Reprocessed ICE Catheter | ABBOTT MEDICAL | OWQ | Class II | 2022-12-19 |
| K222213 | Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) | Unimed Medical Supplies, Inc. | DQA | Class II | 2022-12-19 |
| K221351 | Mechanical Guidewire | Baylis Medical Company, Inc. | DQX | Class II | 2022-12-19 |
| K220881 | INOUE BALLOON A | Toray Industries, Inc. | OZT | Class II | 2022-12-18 |
| K213984 | Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) | Shenzhen Zhengkang Technology Co., Ltd. | DQA | Class II | 2022-12-16 |
| K221267 | VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | MWI | Class II | 2022-12-15 |
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) | Spectranetics, Inc. | DRE | Class II | 2022-12-15 |
| K221245 | PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | LIT | Class II | 2022-12-14 |
| K212957 | BioButton System | Biolntellisense, Inc. | DRG | Class II | 2022-12-12 |
| K222242 | FloPatch FP120 | Flosonics Medical | DPW | Class II | 2022-12-09 |
| K223275 | CELLO II Balloon Guide Catheter | Fuji Systems Corporation | QJP | Class II | 2022-12-09 |
| K222117 | Swang-Ganz IQ pulmonary artery catheter | Edwards Lifesiences, LLC | DYG | Class II | 2022-12-09 |
| K223193 | AIROS 8P Sequential Compression Device | Airos Medical, Inc. | JOW | Class II | 2022-12-09 |
| K223195 | AIROS 6P Sequential Compression Device | Airos Medical, Inc. | JOW | Class II | 2022-12-09 |
| K222038 | CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System | Abbott (Formerly Thoratec Corporation) | QNR | Class II | 2022-12-08 |
| K222837 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | Spectranetics, Inc. | MCW | Class II | 2022-12-08 |
| K223077 | ViewFlex Xtra ICE Catheter | Irvine Biomedical, A St. Jude Medical Company | OBJ | Class II | 2022-12-07 |
| K222019 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) | Stryker Sustainability Solutions | NLF | Class II | 2022-12-04 |
| K221141 | PageWriter TC35 Cardiograph | Medizin Systeme Boblingen GmbH | DPS | Class II | 2022-12-02 |
| K221113 | Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MWI | Class II | 2022-12-02 |
| K220786 | STAR Apollo Mapping System | Rhythm Al, Ltd. | DQK | Class II | 2022-12-01 |
| K222125 | Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G | Shenzhen AOJ Medical Technology Co., Ltd. | DXN | Class II | 2022-12-01 |
| K222297 | CentriMag Pre-connected Pack | Abbott | DTZ | Class II | 2022-12-01 |
| K222652 | Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer | Cardicare Company, Ltd. | DXQ | Class II | 2022-11-28 |
| K221279 | pNOVUS 21 Microcatheter | Phenox, Ltd. | DQO | Class II | 2022-11-28 |
| K222463 | EchoGo Heart Failure | Ultromics Limited | QUO | Class II | 2022-11-23 |
| K222160 | GUS610 Blood pressure monitor | Globalcare Medical Technology Co., Ltd. | DXN | Class II | 2022-11-22 |
| K221530 | ANNE Pediatric | Sibel, Inc. | DRG | Class II | 2022-11-22 |
| K221704 | HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI) | Edwards Lifesciences, LLC | DQK | Class II | 2022-11-22 |
| K222420 | Disposable Blood Pressure Cuff | Wenzhou Xikang Medical Instruments Co., Ltd. | DXQ | Class II | 2022-11-21 |
| K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | DQA | Class II | 2022-11-20 |
| K220351 | Polso Watch | Chronisense Medical, Ltd. | DQA | Class II | 2022-11-18 |
| K220635 | Heater-Cooler System 3T | Livanova Deutschland, GmbH | DWC | Class II | 2022-11-16 |
| K220535 | Cardio10 | Bionet Co., Ltd. | DPS | Class II | 2022-11-15 |
| K211830 | LifeSPARC System | Cardiacassist, Inc. | QNR | Class II | 2022-11-15 |
| K221655 | Multiflex Steerable Sheath | Vizaramed, Inc. | DYB | Class II | 2022-11-14 |
| K221391 | WOLF Thrombectomy SmartClaw Catheter | Devoro Medical, Inc. | QEW | Class II | 2022-11-10 |
| K223178 | SelectSite C304 Deflectable Catheter System, C315 Delivery System | Medtronic | DQY | Class II | 2022-11-08 |
| K203812 | Oxyfit Pulse Oximeter | Shenzhen Viatom Technology Co., Ltd. | DQA | Class II | 2022-11-08 |
| K223127 | HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable | Edwards Lifeciences, LLC | DQK | Class II | 2022-11-07 |
| K222873 | Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system | Medtronic | DQY | Class II | 2022-11-07 |
| K212317 | Eclipse MINI Model 98900 | Spacelabs Healthcare, Ltd. | MWJ | Class II | 2022-11-07 |
| K222679 | Vericor Support Catheter | Vascupatent Medical (Shenzhen) Co., Ltd. | KRA | Class II | 2022-11-07 |
| K221833 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module | Edwards Lifesciences, LLC | DXN | Class II | 2022-11-07 |
| K221822 | BENCHMARK BMX81 Access System | Penumbra, Inc. | QJP | Class II | 2022-11-04 |
| K220466 | ibiomedi Electronic Stethoscope ES-2020 | Sound Land Corp. | DQD | Class II | 2022-11-03 |
| K222550 | Current Health System | Current Health , Ltd. | MSX | Class II | 2022-11-01 |
| K212473 | Welch Allyn Connex Central Station | Welch Allyn, Inc. | MWI | Class II | 2022-10-28 |
| K222631 | VASSALLO GT EXT | Filmecc Co., Ltd. | DQX | Class II | 2022-10-26 |
| K212493 | KODEX EPD System 1.5.0 | Philips Medical Systems Nederland, B.V. (Pmsn) | DQK | Class II | 2022-10-24 |
| K213466 | Houdini Cross Support Catheter | Cruzar Medsystems, Inc. | DQY | Class II | 2022-10-20 |
| K220099 | eClinic Stethopod | Homediagnostic, LLC | DQD | Class II | 2022-10-20 |
| K220527 | PADnet Xpress | Collaborative Care Diagnostics, LLC, D.B.A. Biomedix | JOM | Class II | 2022-10-20 |
| K222842 | V-Patch Cardiac Monitor | Shandong Corecare Technology Limited | DXH | Class II | 2022-10-20 |
| K214073 | eWave Monitor | Wearlinq, Inc. | DSH | Class II | 2022-10-20 |
| K221032 | Vascu-Guard Vascular Repair Patch | Synovis Life Technologies, Inc. | PSQ | Class II | 2022-10-19 |
| K221029 | PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch | Synovis Life Technologies, Inc. | PSQ | Class II | 2022-10-19 |
| K221986 | XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter | Transit Scientific, LLC | PNO | Class II | 2022-10-18 |
| K221321 | MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | DPS | Class II | 2022-10-18 |
| K221372 | YUWELL Electronic Blood Pressure Monitor | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | DXN | Class II | 2022-10-17 |
| K222209 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | 2022-10-17 |
| K221979 | Pulse Oximeter (Model C101A2, C101B1, C101A3) | Shenzhen Imdk Medical Technology Co., Ltd. | DQA | Class II | 2022-10-16 |
| K213857 | HeartFlow Analysis | HeartFlow, Inc. | PJA | Class II | 2022-10-14 |
| K221886 | Sublime Microcatheter | Surmodics,Inc. | DQY | Class II | 2022-10-14 |
| K221857 | Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201 | Zhejiang Lude Technology Development Co., Ltd. | DXQ | Class II | 2022-10-13 |
| K222113 | Abiomed 14Fr Low Profile Introducer Set | Abiomed, Inc. | DYB | Class II | 2022-10-13 |
| K221913 | Arm Blood Pressure Monitor | Alicn Medical Shenzhen, Inc. | DXN | Class II | 2022-10-12 |
| K203638 | AT-Patch ECG Analysis System | Atsens Co., Ltd. | DSH | Class II | 2022-10-12 |
| K221951 | Branchor Balloon Guide Catheter | Asahi Intecc Co., Ltd. | QJP | Class II | 2022-10-11 |
| K221764 | InBody Blood pressure monitor, Model BPBIO480KV | Inbody Co., Ltd. | DXN | Class II | 2022-10-07 |
| K221575 | Pre-Formed Blue | Lake Region Medical | DQX | Class II | 2022-10-07 |
| K213666 | NuCath Wedge Pressure Catheter | Pfm Medical, Inc. | DQO | Class II | 2022-10-06 |
| K212168 | A&D Medical UM-212BLE Blood Pressure Monitor | A&D Company, Ltd. | DXN | Class II | 2022-10-06 |
| K220683 | INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) | Penumbra, Inc. | QEW | Class II | 2022-10-04 |
| K222743 | Route 92 Medical Full Length 070 Access System | Route 92 Medical, Inc. | QJP | Class II | 2022-10-04 |
| K220220 | Electronic Sphygmomanometer (Model: LT-P30) | Zhuhai Linte Medical Instrument Co., Ltd. | DXN | Class II | 2022-10-03 |
| K213023 | Blood Pressure Monitor(Model:Y30001) | Zhangzhou Easepal Medical Science and Technology Co., Ltd. | DXN | Class II | 2022-09-30 |
| K221397 | MitraClip G4 Steerable Guide Catheter | ABBOTT MEDICAL | DRA | Class II | 2022-09-28 |
| K212143 | Neteera 130H/131H Vital Sign Monitoring Sensor | Neteera Technologies , Ltd. | DRT | Class II | 2022-09-28 |
| K220795 | QT ECG | QT Medical, Inc. | DXH | Class II | 2022-09-26 |
| K220116 | Auryon Atherectomy Catheters | Eximo Medical, Ltd. | MCW | Class II | 2022-09-26 |
| K220941 | HotDog Temperature Management System | Augustine Temperature Management | DWJ | Class II | 2022-09-23 |
| K222568 | OptiCross 18 Peripheral Imaging Catheter | Boston Scientific Corporation | OBJ | Class II | 2022-09-23 |
| K212615 | EpiFaith CV | Flat Medical Co., Ltd. | DQX | Class II | 2022-09-21 |
| K214048 | Millipede 088 Access Catheter | Perfuze, Ltd. | QJP | Class II | 2022-09-20 |
| K214060 | LANDMARK REBOA Catheter | Zien Medical Technologies, Inc. | MJN | Class II | 2022-09-19 |
| K221707 | SafeSept® Transseptal Guidewire (SS-140) | Pressure Products Medical Device Manufacturing, LLC | DRC | Class II | 2022-09-14 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.