Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 55
- Latest Decision
- 2024-05-28
Clearances · page 10 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K233076 | Laser Speckle Imaging System (RFLSI CZW) | Rwd Life Science Co., Ltd. | DPT | Class II | 2024-05-28 |
| K240864 | PacePro Wire | Opsens, Inc. | DQX | Class II | 2024-05-24 |
| K232788 | INSPIRA ART100 | Inspira Technologies Oxy B.H.N. , Ltd. | DWA | Class II | 2024-05-24 |
| K233268 | Impress Angiographic Catheter | Merit Medical Systems, Inc. | DQO | Class II | 2024-05-22 |
| K233820 | Fogarty Arterial Embolectomy Catheter with Gate Valve | Edwards Lifesciences | DXE | Class II | 2024-05-22 |
| K233819 | Fogarty Venous Thrombectomy Catheters | Edwards Lifesciences, LLC | DXE | Class II | 2024-05-22 |
| K233619 | Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters | Edwards Lifesciences | DXE | Class II | 2024-05-20 |
| K223399 | AViTA Pulse Oximeter | Avita Corporation | DQA | Class II | 2024-05-20 |
| K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) | Pressure Products Medical Device Manufacturing, LLC | DRC | Class II | 2024-05-17 |
| K232495 | Sempulse Halo Vital Signs Monitor | Sempulse Corporation | DQA | Class II | 2024-05-16 |
| K232542 | Wedge XL Delivery Catheter | MicroVention, Inc. | QJP | Class II | 2024-05-16 |
| K241053 | MVR Venous Reservoir Bag 800 mL; MVR Venous Reservoir Bag 1600 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 800 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 1600 mL | Medtronic Cardiac Surgery | DTN | Class II | 2024-05-15 |
| K232662 | BNLE Hydrophilic Jacketed Peripheral Guidewire | Biomerics Nle | DQX | Class II | 2024-05-14 |
| K233982 | CEREGLIDE 92 Catheter System | Cerenovus, Inc. | QJP | Class II | 2024-05-09 |
| K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | MSX | Class II | 2024-05-09 |
| K240954 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | Shockwave Medical, Inc. | PPN | Class II | 2024-05-07 |
| K240377 | LIFEPAK® ECG Cables | Stryker Physio-Control | DSA | Class II | 2024-05-07 |
| K233864 | ASSURE Wearable ECG | Kestra Medical Technologies, Inc. | MWJ | Class II | 2024-05-07 |
| K234021 | Masimo Stork | Masimo Corporation | QYU | Class II | 2024-05-03 |
| K232445 | CSF-4 (CSF-4) | Cardiacsense | DPS | Class II | 2024-05-02 |
| K240261 | Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) | Merit Medical Systems, Inc. | KRD | Class II | 2024-05-02 |
| K240900 | HOTWIRE RF Guidewire | Atraverse Medical | DXF | Class II | 2024-05-01 |
| K240829 | AuST Steerable Sheath | CenterPoint Systems, LLC | DYB | Class II | 2024-05-01 |
| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) | Physio-Control, Inc. | DSA | Class II | 2024-04-30 |
| K240102 | Blood Pressure Monitor (TMB-2287-B) | Guangdong Transtek Medical Electronics Co., Ltd. | DXN | Class II | 2024-04-29 |
| K232261 | TME Temporary Myocardial Electrode | Osypka AG | LDF | Class II | 2024-04-26 |
| K234065 | CDI OneView Monitoring System | Terumo Cardiovascular Systems Corporation | DRY | Class II | 2024-04-25 |
| K233810 | Portrait VSM | Ge Medical Systems Information Technologies, Inc. | MWI | Class II | 2024-04-25 |
| K233948 | Provisio SLT IVUS System | Provisio Medical, Inc. | OBJ | Class II | 2024-04-23 |
| K233329 | Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set | Route 92 Medical, Inc. | NRY | Class II | 2024-04-23 |
| K234041 | Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS) | Andon Health Co, Ltd. | DXN | Class II | 2024-04-22 |
| K240534 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | QHW | Class II | 2024-04-19 |
| K233737 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | IZQ | Class II | 2024-04-19 |
| K240162 | LIFEPAK® 35 AC Power Adapter (41335-000001) | Stryker Physio-Control | MPD | Class II | 2024-04-19 |
| K234073 | ICE Aspiration System | Expanse Medical, Inc. | QEW | Class II | 2024-04-19 |
| K232962 | Patient Monitor (iX10, iX12, iX15) | Edan Instruments, Inc. | MHX | Class II | 2024-04-19 |
| K232627 | HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC | DWJ | Class II | 2024-04-18 |
| K233924 | EMBOGUARD Balloon Guide Catheter | Neuravi Limited | QJP | Class II | 2024-04-18 |
| K232926 | Novalung ultimate kit (US) | Fresenius Medical Care Renal Therapies Group, LLC | QJZ | Class II | 2024-04-15 |
| K233313 | Keikku Electronic stethoscope | Lapsi Health Holding B.V. | DQD | Class II | 2024-04-10 |
| K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. | KRH | Class II | 2024-04-09 |
| K232823 | MCG-S (AM1000) | Amcg Co., Ltd. | DPS | Class II | 2024-04-05 |
| K233249 | APPRAISE-HRI | The Surgeon General, Department of the Army (TSG-DA) | SAR | Class II | 2024-04-05 |
| K233666 | CorVista System with PH Add-On | Analytics For Life, Inc. | SAT | Class II | 2024-04-05 |
| K232037 | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath | Innovative Health, LLC | PNE | Class II | 2024-04-04 |
| K233975 | Zoom 6F Insert Catheters | Imperative Care, Inc. | DQO | Class II | 2024-04-02 |
| K240601 | SnapshotNIR model KD205 | Kent Imaging, Inc. | MUD | Class II | 2024-04-02 |
| K240397 | AlphaVac MMA F1885 System (H787253020) | AngioDynamics, Inc. | QEZ | Class II | 2024-04-01 |
| K233133 | Talis EMR with Talis +ACG (Talis EMR with +ACG) | Talis Clinical, LLC | MWI | Class II | 2024-04-01 |
| K240693 | LINQ II Insertable Cardiac Monitor (ICM) | Medtronic, Inc. | MXD | Class II | 2024-03-28 |
| K233409 | Eko Low Ejection Fraction Tool (ELEFT) | Eko Health, Inc. | QYE | Class II | 2024-03-28 |
| K233909 | Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner Plus 18F Handpiece with Maceration Wire, Cleaner Plus 18F Aspiration Canister | Argon Medical Devices, Inc. | QEW | Class II | 2024-03-28 |
| K232013 | Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040) | Goodman Co., Ltd. | PNO | Class II | 2024-03-28 |
| K233609 | CORE 500 Digital Stethoscope | Eko Health, Inc. | DQD | Class II | 2024-03-28 |
| K231972 | Advanta VXT Vascular Graft, Flixene Vascular Graft | Atrium Medical Corporation | DSY | Class II | 2024-03-28 |
| K233201 | MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) | Penumbra, Inc. | QJP | Class II | 2024-03-27 |
| K231984 | Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP) | Shenzhen Hingmed Medical Instrument Co., Ltd. | DXN | Class II | 2024-03-26 |
| K240589 | Micropuncture Introducer Sets; Micropuncture Pedal Access Sets | Cook Medical | DYB | Class II | 2024-03-25 |
| K232548 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | MSX | Class II | 2024-03-22 |
| K240225 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | Shockwave Medical, Inc. | PPN | Class II | 2024-03-22 |
| K232354 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software | Murata Vios, Inc. | DRT | Class II | 2024-03-22 |
| K234130 | Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O | Ge Medical Systems Information Technologies, Inc. | MWI | Class II | 2024-03-20 |
| K240165 | Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer | Wenzhou Longwan Medical Device Factory | DXQ | Class II | 2024-03-20 |
| K233146 | Blood Pressure Monitor | Shenzhen Jamr Technology Co., Ltd. | DXN | Class II | 2024-03-19 |
| K240117 | Aventus Thrombectomy System (IM-2001/IM-0002) | Inquis Medical | QEW | Class II | 2024-03-15 |
| K233799 | Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R) | Shenzhen Yuezhongxing Technology Co., Ltd. | DXN | Class II | 2024-03-15 |
| K234115 | APRO 55 Catheter | Alembic, LLC | DQY | Class II | 2024-03-15 |
| K233853 | LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | DQK | Class II | 2024-03-14 |
| K240384 | SENDERO Microcatheter | Okami Medical, Inc. | DQY | Class II | 2024-03-08 |
| K233943 | Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) | Medtronic, Inc. | DQK | Class II | 2024-03-08 |
| K233038 | Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s | Edan Instruments, Inc. | MWI | Class II | 2024-03-08 |
| K231056 | Esperance Distal Access Catheter | Wallaby Medical | QJP | Class II | 2024-03-08 |
| K232207 | D·Kutting PTA Scoring Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | PNO | Class II | 2024-03-07 |
| K232270 | DVT Motion Pneumatic Compression Device | Koge Micro Tech Co., Ltd. | JOW | Class II | 2024-03-06 |
| K231288 | Vyvo | Vyvo Technology Corp.(Vt) | DQA | Class II | 2024-03-04 |
| K232385 | OxiplexTS200 | Iss Medical, Inc. | MUD | Class II | 2024-03-01 |
| K240083 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | DSY | Class II | 2024-03-01 |
| K232971 | APRO 55 Catheter and Alembic Aspiration Tubing | Alembic, LLC | NRY | Class II | 2024-02-29 |
| K240257 | Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery Kit | Bd | DTK | Class II | 2024-02-29 |
| K232562 | PowerWire Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. | PDU | Class II | 2024-02-28 |
| K233488 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | MUD | Class II | 2024-02-28 |
| K240190 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated | Medtronic | DTR | Class II | 2024-02-23 |
| K240011 | Lymphedema Compression | Jkh Health Co., Ltd. | JOW | Class II | 2024-02-23 |
| K232536 | Soldier Microcatheter | Embolx, Inc. | DQO | Class II | 2024-02-23 |
| K240193 | R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) | Sorin Group Italia S.R.L. | DWF | Class II | 2024-02-22 |
| DEN230064 | BraidE Embolization Assist Device | Rapid Medical Ltd. | QZU | Class II | 2024-02-21 |
| K232502 | Cocoon Convective Warming System, Model CWS7000 | Care Essentials Pty, Ltd. | DWJ | Class II | 2024-02-21 |
| K240119 | VasQ | Laminate Medical Technologies , Ltd. | QVQ | Class II | 2024-02-16 |
| K233906 | S-Patch (S-Patch ExL) | Wellysis Corp. | DSH | Class II | 2024-02-16 |
| K233708 | NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) | Synaptic Medical Corporation | DYB | Class II | 2024-02-16 |
| K233483 | FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) | Cardio Flow Inc., | MCW | Class II | 2024-02-15 |
| K234123 | Easi-Vue® embolic microspheres System | Abk Biomedical, Inc. | KRD | Class II | 2024-02-13 |
| K233959 | EPi-Ease Epicardial Access Device (EAS) | AtriCure, Inc. | DYB | Class II | 2024-02-13 |
| K231733 | Neteera 130H-Plus Vital Sign Monitoring Sensor | Neteera Technologies , Ltd. | DRT | Class II | 2024-02-09 |
| K234034 | VenaCore Thrombectomy Catheter (46-101) | Inari Medical, Inc. | QEW | Class II | 2024-02-09 |
| K233350 | SINC Support Catheter | Reflow Medical, Inc. | DQY | Class II | 2024-02-08 |
| K232694 | Central Monitoring System (MFM-CMS) | Edan Instruments, Inc. | MHX | Class II | 2024-02-05 |
| K233895 | EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B); | Edwards Lifesciences | DWF | Class II | 2024-02-05 |
| K240030 | Indigo® Aspiration System - Lightning® Flash | Penumbra, Inc. | QEW | Class II | 2024-02-02 |
| K240018 | WATCHMAN TruSteer Access System (M635TU90050) | Boston Scientific Corporation | DQY | Class II | 2024-02-01 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.