FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×

18,110 results

10177–10200 of 18,110

Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular

Cleared Apr 11, 1997

IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM

Irvine Biomedical, Inc.

Cardiovascular · 329d

Cleared Apr 10, 1997

Vision Electronics

Cardiovascular · 255d

Cleared Apr 09, 1997

VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW...

Vasamedics, LLC

Cardiovascular · 271d

Cleared Apr 09, 1997

3M RED DOT 2560 & 2570 MONITORING ELECTRODES

Cardiovascular · 36d

Cleared Apr 04, 1997

FLEXIBLE DILATING SHEATH

Med Institute, Inc.

Cardiovascular · 872d

Cleared Apr 04, 1997

HEARTPORT ENDOAORTIC CLAMP

Heartport, Inc.

Cardiovascular · 169d

Cleared Apr 03, 1997

CTS MIDCAB CORONARY SHUNT

Cardiothoracic Systems, Inc.

Cardiovascular · 212d

Cleared Apr 02, 1997

SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE

Spacelabs Medical, Inc.

Cardiovascular · 646d

Cleared Apr 02, 1997

MICS DEVICE SYSTEM

Percutaneous Technologies, Inc.

Cardiovascular · 198d

Cleared Apr 01, 1997

CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER

Citizen Watch Co., Ltd.

Cardiovascular · 550d

Not Cleared Apr 01, 1997

OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR

Oscor Medical Corp.

Cardiovascular · 168d

Cleared Apr 01, 1997

D SERIES ELECTRODE

Cmc Sense-It, Inc.

Cardiovascular · 42d

Cleared Mar 28, 1997

AIRCAST VENAFLOW SYSTEM (MODIFICATION)

Cardiovascular · 350d

Cleared Mar 28, 1997

FOCUS PV BALLOON DILATATION CATHETER

Cardiovascular Dynamics, Inc.

Cardiovascular · 193d

Cleared Mar 28, 1997

COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)

Coeur Laboratories, Inc.

Cardiovascular · 88d

Cleared Mar 28, 1997

SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES

Scimed Life Systems, Inc.

Cardiovascular · 65d

Cleared Mar 28, 1997

DUAL LUMEN EMBOLECTOMY CATHETER

Applied Medical Resources

Cardiovascular · 25d

Cleared Mar 26, 1997

Cardiac Assist Devices, Inc.

Cardiovascular · 400d

Cleared Mar 25, 1997

SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION

Spacelabs Medical, Inc.

Cardiovascular · 237d

Cleared Mar 24, 1997

Target Therapeutics

Cardiovascular · 90d

Cleared Mar 21, 1997

FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER

Fukuda Denshi USA, Inc.

Cardiovascular · 227d

Cleared Mar 21, 1997

CES INFUSION CATHETER

Cordis Neurovascular, Inc.

Cardiovascular · 87d

Cleared Mar 20, 1997

CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4

International Biophysics Corp.

Cardiovascular · 185d

Cleared Mar 20, 1997

IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT

Cardiovascular · 105d