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
13369–13392 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 27, 1988
TAD INTERMEDIATE & TAD STANDARD GUIDE WIRE
K882928 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 81d
Cleared Sep 27, 1988
PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP
K882981 · DWS
Pioneering Technologies, Inc.
Cardiovascular · 74d
Cleared Sep 26, 1988
FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT
K881632 · JOW
Huntleigh Technology, Inc.
Cardiovascular · 165d
Cleared Sep 26, 1988
VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER
K881851 · DSB
Micro Medical, Ltd.
Cardiovascular · 147d
Cleared Sep 26, 1988
VASCULAR ACCESS PORT/CATHETER NO.VP-XXX VASPORT
K882969 · DQY
Gish Biomedical, Inc.
Cardiovascular · 73d
Cleared Sep 26, 1988
SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2A
K883053 · DTZ
Scimed Life Systems, Inc.
Cardiovascular · 69d
Cleared Sep 26, 1988
SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & II
K883054 · DTZ
Scimed Life Systems, Inc.
Cardiovascular · 69d
Cleared Sep 26, 1988
PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE)
K883135 · DWS
Pioneering Technologies, Inc.
Cardiovascular · 62d
Cleared Sep 26, 1988
BASIC HEATER-COOLER UNIT, 115/100V 16-02-20
K883330 · DTR
Shiley, Inc.
Cardiovascular · 49d
Cleared Sep 26, 1988
BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10
K883331 · DTR
Shiley, Inc.
Cardiovascular · 49d
Cleared Sep 26, 1988
MAST FOR BASIC HEATER-COOLER UNIT 16-09-00
K883332 · DTR
Shiley, Inc.
Cardiovascular · 49d
Cleared Sep 26, 1988
SIMPSON PERIPHERAL ATHEROCATH W/ADDIT. SIZE 13F
K883346 · LIT
Devices For Vascular Intervention, Inc.
Cardiovascular · 60d
Cleared Sep 23, 1988
CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066
K882427 · DXY
Ela Medical, Inc.
Cardiovascular · 102d
Cleared Sep 22, 1988
EPICARDIA PC/FC
K883103 · DSI
Medicomp, Inc.
Cardiovascular · 62d
Cleared Sep 20, 1988
HOLTER SCANNER
K881488 · DSI
Cardiodata Corp.
Cardiovascular · 165d
Cleared Sep 20, 1988
JOBST EXTREMITY PUMP(R) SYSTEM 7500
K882683 · JOW
Jobst Institute, Inc.
Cardiovascular · 82d
Cleared Sep 20, 1988
Q-CATH RM
K883031 · DXJ
Quinton, Inc.
Cardiovascular · 63d
Cleared Sep 20, 1988
QUIK-PACE II ELECTRODES
K883121 · DRO
Physio-Control Corp.
Cardiovascular · 56d
Cleared Sep 19, 1988
MODIFIED LASERFLO BLOOD PERFUSION MONITOR, BPM403A
K875179 · DPW
Tsi, Inc.
Cardiovascular · 277d
Cleared Sep 16, 1988
BARO-GRAF 24
K881297 · DRS
Instromedix, Inc.
Cardiovascular · 172d
Cleared Sep 16, 1988
PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE
K882655 · DQO
Procedure Packs, Inc.
Cardiovascular · 79d
Cleared Sep 16, 1988
PROCEDURE PACKS SOLUTION ADMINISTRATION SETS
K882716 · DQD
Procedure Packs, Inc.
Cardiovascular · 77d
Cleared Sep 16, 1988
SCIMED R30 SILICONE ASSIST RESERVOIR
K882720 · DTN
Scimed Life Systems, Inc.
Cardiovascular · 77d
Cleared Sep 16, 1988
ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST
K882803 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 71d