Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 51
- Latest Decision
- 2024-08-28
Clearances · page 9 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K240078 | Fogarty Thru-Lumen Embolectomy Catheter | Edwards Lifesciences, LLC | DXE | Class II | 2024-08-28 |
| K242212 | Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) | Nemoto Kyorindo Co., Ltd. | DXT | Class II | 2024-08-27 |
| K241538 | TriClip Steerable Guide Catheter | ABBOTT MEDICAL | DQY | Class II | 2024-08-26 |
| K241850 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | IZQ | Class II | 2024-08-26 |
| K242169 | Morph DNA Steerable Introducer Sheath | Biocardia | DYB | Class II | 2024-08-23 |
| K241109 | Single-use Sterile High-pressure Angiographic Syringes and Accessories | Shenzhen Boon Medical Supply Co., Ltd. | DXT | Class II | 2024-08-22 |
| K242248 | Introducer Sheath Kits | Beijing Demax Medical Technology Co.,Ltd | DYB | Class II | 2024-08-22 |
| K241351 | Blood Pressure Monitor (TMB-2092-G) | Guangdong Transtek Medical Electronics Co., Ltd. | DXN | Class II | 2024-08-21 |
| K240859 | Glidewire GT-R | Terumo Corporation | DQX | Class II | 2024-08-21 |
| K233755 | HeartKey® Rhythm | B-Secur Limited | DQK | Class II | 2024-08-16 |
| K233499 | Sapphire NC ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | LOX | Class II | 2024-08-16 |
| K231979 | Mecun SpO2 sensor | Shenzhen Mecun Medical Supply Co., Ltd. | DQA | Class II | 2024-08-16 |
| K233505 | Sapphire ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | LOX | Class II | 2024-08-15 |
| K241510 | CROSSLEAD Tracker | Asahi Intecc Co., Ltd. | DQX | Class II | 2024-08-14 |
| K240957 | Catapult Guide Sheath | Contract Medical International, GmbH | DYB | Class II | 2024-08-14 |
| K242016 | EnSite X EP System | ABBOTT MEDICAL | DQK | Class II | 2024-08-09 |
| K240229 | Masimo W1 | Masimo Corporation | DPS | Class II | 2024-08-08 |
| K233702 | SMARxT Tubing and Connectors | LivaNova USA, Inc. | DWE | Class II | 2024-08-08 |
| K233433 | Sphere-9Dx Diagnostic Catheter (AFR-00009) | Medtronic | MTD | Class II | 2024-08-07 |
| K241708 | Abiomed 14Fr Low Profile Introducer Kit | Abiomed, Inc. | DYB | Class II | 2024-08-06 |
| K240909 | Samsung ECG App v 1.3 (ECG) | Samsung Electronics Co., Ltd. | QDA | Class II | 2024-08-02 |
| K233984 | Acumen Assisted Fluid Management (AFM) Software Feature | Edwards Lifesciences, LLC | QMS | Class II | 2024-08-02 |
| K241145 | TLAB® Transvenous Liver Biopsy System (TF-18C) | Argon Medical Devices, Inc. | DYB | Class II | 2024-08-01 |
| K240312 | Infinity CentralStation Wide | Draeger Medical Systems, Inc. | MHX | Class II | 2024-08-01 |
| K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System | B.Braun Medical, Inc. | DTK | Class II | 2024-07-31 |
| K240967 | ValvuloPro Valvuloplasty Balloon Catheter | Dongguan TT Medical, Inc. | OZT | Class II | 2024-07-31 |
| K240509 | STAR Apollo Mapping System | Rhythm AI, Ltd. | DQK | Class II | 2024-07-26 |
| K240246 | Accusafe Transseptal Guidewire (GTR31180, GTR31230) | Synaptic Medical Corporation | DRC | Class II | 2024-07-26 |
| K241243 | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) | Centerline Biomedical, Inc. | DQK | Class II | 2024-07-24 |
| K240756 | AITRICS-VC | Aitrics Co., Ltd. | PLB | Class II | 2024-07-23 |
| K240558 | NAVOYCDS | Algodx AB | PLB | Class II | 2024-07-22 |
| K233976 | VasoGuard (V10, V8, V6, V4, V2) | Corvascular Diagnostics, LLC | JOP | Class II | 2024-07-19 |
| K233917 | ICHOR 7F Embolectomy System (ICH-7F) | Ichor | QEW | Class II | 2024-07-18 |
| K241206 | Quantum Perfusion Hybrid System | Spectrum Medical S.R.L. | DTN | Class II | 2024-07-18 |
| K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ | Acist Medical Systems, Inc. | DXO | Class II | 2024-07-17 |
| K241740 | Finesse Injectable PTA Balloon Dilatation Catheter | Summa Therapeutics | LIT | Class II | 2024-07-16 |
| K233834 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | MSX | Class II | 2024-07-12 |
| K241720 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | DRE | Class II | 2024-07-12 |
| K241711 | Oscar Peripheral Multifunctional Catheter system | Biotronik, Inc. | LIT | Class II | 2024-07-11 |
| K233791 | Drivewire 24 Guidewire | Rapid-Medical , Ltd. | MOF | Class II | 2024-07-11 |
| K241683 | Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031406020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031408020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031410020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031412020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031415020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H749390314 | Boston Scientific Corporation | LIT | Class II | 2024-07-10 |
| K240666 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS) | Medtronic Perfusion Systems | DTZ | Class II | 2024-07-10 |
| K241372 | Advisor HD Grid X Mapping Catheter, Sensor Enabled | ABBOTT MEDICAL | MTD | Class II | 2024-07-09 |
| K233584 | RhythmStar System | RhythMedix, LLC | QYX | Class II | 2024-07-08 |
| K241129 | Upper Arm Electronic Blood Pressure Monitor | Shenzhen Goodlymed Technology Co., Ltd. | DXN | Class II | 2024-07-03 |
| K234083 | Next Generation Aspiration Catheter; Balt Aspiration Tubing Set | Balt USA, LLC | NRY | Class II | 2024-07-02 |
| K241330 | Fogarty Fortis Arterial Embolectomy Catheter | Edwards Lifesciences | DXE | Class II | 2024-07-02 |
| K234074 | Next Generation Access Catheter | Balt USA, LLC | QJP | Class II | 2024-07-02 |
| K231015 | Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters | Innovative Health, LLC | NLI | Class II | 2024-07-01 |
| K232989 | Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E) | Shenzhen AOJ Medical Technology Co., Ltd. | DQA | Class II | 2024-07-01 |
| K241540 | NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter | Biosense Webster, Inc. | OBJ | Class II | 2024-06-28 |
| K233637 | Cordis BRITECROSS Support Catheter | Cordis US Corp | DQY | Class II | 2024-06-28 |
| K240320 | Patient Monitor (RespArray) | Edan Instruments, Inc. | MHX | Class II | 2024-06-28 |
| K233357 | EsoCool Thermal Regulation Catheter | Nuvaira, Inc. | PLA | Class II | 2024-06-27 |
| K241553 | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating | Eximo Medical, Ltd. | MCW | Class II | 2024-06-27 |
| K233983 | Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) | Edwards Lifesciences | DYG | Class II | 2024-06-27 |
| K233354 | WVSM Pro (Series) (500-0030-XX) | Athena Gtx, Inc. | MWI | Class II | 2024-06-26 |
| K241507 | ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) | Aln S.A.R.L. | DTK | Class II | 2024-06-26 |
| K232111 | NeoBeat, NeoBeat Mini | Laerdal Medical AS | MWI | Class II | 2024-06-25 |
| K241158 | ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3 | Asahi Intecc Co., Ltd. | DQY | Class II | 2024-06-25 |
| K232640 | Venowave VW5 | Thermabright | JOW | Class II | 2024-06-25 |
| K240125 | Therm-X (Home); Therm-X (AT) | Zenith Technical Innovations | JOW | Class II | 2024-06-21 |
| K240387 | MINAMO blue; MINAMO viola | Asahi Intecc Co., Ltd. | DQX | Class II | 2024-06-21 |
| K232975 | Pulse Oximeter (MD300C228) | Beijing Choice Electronic Technology Co., Ltd. | DQA | Class II | 2024-06-21 |
| K234155 | Nimbl (model PD08-N1) | Tactile Medical | JOW | Class II | 2024-06-21 |
| K233549 | Tempus ECG-AF | Tempus AI, Inc. | SBQ | Class II | 2024-06-21 |
| K233253 | eCARTv5 Clinical Deterioration Suite (eCART) | Agilemd, Inc. | QNL | Class II | 2024-06-21 |
| K233326 | Merge Hemo, Model RCSV2 | Merge Healthcare Incorporated | DQK | Class II | 2024-06-21 |
| K232161 | DeepRhythm Platform | Medicalgorithmics S.A. | DPS | Class II | 2024-06-20 |
| K232258 | XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter | Transit Scientific, LLC | PNO | Class II | 2024-06-17 |
| K231116 | Multi-parameter detector | Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. | MNW | Class II | 2024-06-15 |
| K240729 | Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61) | Shenzhen Pango Medical Electronics Co., Ltd. | DXN | Class II | 2024-06-14 |
| K230668 | Disposable High-pressure Extension Lines | Precision Medical Plastics , Ltd. | DXT | Class II | 2024-06-14 |
| K241370 | Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED) | ABBOTT MEDICAL | DYB | Class II | 2024-06-13 |
| K240460 | FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) | FMD Co., Ltd. | DQX | Class II | 2024-06-13 |
| K233266 | MEDIBLU ECG SYSTEM | Mediblu Medical, LLC | DPS | Class II | 2024-06-12 |
| K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B) | Medtronic, Inc. | DTZ | Class II | 2024-06-12 |
| K240050 | SOUNDSTAR CRYSTAL Ultrasound Catheter | Biosense Webster, Inc. | OBJ | Class II | 2024-06-12 |
| DEN230069 | Mi-CHORD System | Lsi Solutions, Inc. | SBK | Class II | 2024-06-11 |
| K241025 | JADE PLUS PTA Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | LIT | Class II | 2024-06-11 |
| K241399 | Indigo® Lightning Flash Aspiration System Select + Catheter | Penumbra, Inc. | QEW | Class II | 2024-06-10 |
| K233825 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | Innovative Health | NLH | Class II | 2024-06-07 |
| K240972 | Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) | Surgical Instrument Service and Savings, Inc. | NLH | Class II | 2024-06-07 |
| K232804 | FibriCheck | Qompium NV | QME | Class II | 2024-06-07 |
| K232035 | Impala | AliveCor, Inc. | DPS | Class II | 2024-06-07 |
| K232816 | Electrocardiograph, model: ECG301 | Shenzhen LE Medical Technology Co., Ltd. | DPS | Class II | 2024-06-07 |
| K231010 | Corvair | AliveCor, Inc. | MHX | Class II | 2024-06-07 |
| K240832 | Blood Pressure Monitor (BBZ32-AA01) | Guangdong Transtek Medical Electronics Co., Ltd. | DXN | Class II | 2024-06-07 |
| K233824 | Swan-Ganz catheter | Edwards Lifesciences, LLC | DYG | Class II | 2024-06-06 |
| K240948 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support | Imperative Care, Inc. | QJP | Class II | 2024-06-06 |
| K240251 | ANNE Chest | Sibel Health, Inc. | DRG | Class II | 2024-06-03 |
| K241259 | Amplatz Goose Neck Snare Kit | Medtronic, Inc. | MMX | Class II | 2024-06-03 |
| K233729 | Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58 | Vascular Solutions, LLC | LOX | Class II | 2024-05-31 |
| K241248 | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) | Spectrum Medical S.R.L. | DWF | Class II | 2024-05-31 |
| K240254 | Blood Pressure Monitor (TMB-2296-BT) | Guangdong Transtek Medical Electronics Co., Ltd. | DXN | Class II | 2024-05-31 |
| K234003 | The Circadia C200 System | Circadia Technologies, Ltd. | DRT | Class II | 2024-05-30 |
| K232934 | Sunsphere | Hangzhou Yangshun Medical Technology Co.,Ltd | KRD | Class II | 2024-05-30 |
| K241207 | SmartClaw Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw Thrombectomy Catheter, 32 mm (FD0660-02) | Devoro Medical, Inc. | QEW | Class II | 2024-05-29 |
| K240305 | ANNE Limb | Sibel Health, Inc. | DQA | Class II | 2024-05-28 |
| K241177 | React 71 Catheter | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | DQY | Class II | 2024-05-28 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.