FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×

18,053 results

11689–11712 of 18,053

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

Cleared Sep 25, 1992

OCCLUSION BALLON CATHETER MODIFICAION

Interventional Therapeutics Corp.

Cardiovascular · 185d

Cleared Sep 23, 1992

BAXTER SENSOR CORONARY GUIDEWIRE

Baxter Healthcare Corp

Cardiovascular · 83d

Cleared Sep 23, 1992

LIFE-TEL T.R.S.

Raco Products Co.

Cardiovascular · 70d

Cleared Sep 22, 1992

MODEL P-81 CRITIKON PRINTER

Cardiovascular · 292d

Cleared Sep 22, 1992

ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF

Pioneering Technologies, Inc.

Cardiovascular · 168d

Cleared Sep 21, 1992

PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH

Baxter Healthcare Corp

Cardiovascular · 276d

Cleared Sep 21, 1992

MERI-DAPT(TM) HEMOSTASIS VALVE/TORQLOC TORQUE DEVI

Merit Medical Systems, Inc.

Cardiovascular · 164d

Cleared Sep 18, 1992

GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION)

General Devices

Cardiovascular · 147d

Cleared Sep 18, 1992

CONDUCER CARDIOPLEGIA SET SITH MP4

3M Health Care, Ltd.

Cardiovascular · 88d

Cleared Sep 18, 1992

MODEL #340 STEALTH-TRODE+LS

Cardiotronics, Inc.

Cardiovascular · 74d

Cleared Sep 18, 1992

CONDUCER HEAT EXCHANGER

3M Health Care, Sarns

Cardiovascular · 73d

Cleared Sep 17, 1992

CORDIS 6 FRENCH PARAGON ANGIOGRAPHIC CATHETER

Cardiovascular · 182d

Cleared Sep 16, 1992

EDM(R) INFUSION CATHETER

Peripheral Systems Group

Cardiovascular · 315d

Cleared Sep 15, 1992

MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS

Medtronic Vascular

Cardiovascular · 216d

Cleared Sep 15, 1992

CENTRI-SAFE(TM) VALVE

Cardio Systems, Inc.

Cardiovascular · 168d

Cleared Sep 11, 1992

MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD

Cook Pacemaker Corp.

Cardiovascular · 298d

Cleared Sep 09, 1992

CORDIS SHUTTLE CATHETER W/ SIDEHOLES

Cardiovascular · 175d

Cleared Sep 04, 1992

4240 DYNAMIC BP/HEART RATE MONITOR

Suntech Medical Instruments, Inc.

Cardiovascular · 347d

Cleared Sep 04, 1992

MODEL ELI 200 ELECTROCARDIOGRAPH

Mortara Instrument, Inc.

Cardiovascular · 219d

Cleared Sep 04, 1992

MODEL ELI 100 ELECTROCARDIOGRAPH

Mortara Instrument, Inc.

Cardiovascular · 219d

Cleared Sep 03, 1992

AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR

Electromedics, Inc.

Cardiovascular · 258d

Cleared Sep 03, 1992

DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS

Nihon Kohden America, Inc.

Cardiovascular · 202d

Cleared Sep 01, 1992

LUKENS 2-0 BRAIDED SILK SUTURES

Cardiovascular · 203d

Cleared Aug 24, 1992

TEC ROTATING DUAL HEMOVALVE

Intensive Technology, Inc.

Cardiovascular · 433d