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
13345–13368 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 13, 1988
EP-STAT
K883152 · DQK
Coherent Systems, Inc.
Cardiovascular · 79d
Cleared Oct 13, 1988
PTI INTRA-ART INTER MAMM ARTERY PAPAVER INFUS KIT
K883221 · DWF
Pioneering Technologies, Inc.
Cardiovascular · 76d
Cleared Oct 13, 1988
TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CM
K883358 · DXH
Telescan Medical Systems
Cardiovascular · 65d
Cleared Oct 13, 1988
INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM
K883439 · DTR
Medtronic Blood Systems, Inc.
Cardiovascular · 59d
Cleared Oct 07, 1988
SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER
K873674 · JOP
Shimadzu Corp.
Cardiovascular · 392d
Cleared Oct 06, 1988
POCKET MANOMETER
K880599 · DXN
Abbott Laboratories
Cardiovascular · 238d
Cleared Oct 06, 1988
PACER SENSING ANALYZER (PSA 100)
K882327 · DTC
Oscor Medical Corp.
Cardiovascular · 122d
Cleared Oct 06, 1988
SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR
K882380 · DTN
Scimed Life Systems, Inc.
Cardiovascular · 119d
Cleared Oct 06, 1988
POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP
K883015 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 79d
Cleared Oct 06, 1988
USCI SOFT-TIP ANGIOGRAPHIC CATHETER
K883051 · DQO
C.R. Bard, Inc.
Cardiovascular · 79d
Cleared Oct 06, 1988
TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE
K883523 · DRO
Cardiotronics, Inc.
Cardiovascular · 50d
Cleared Oct 06, 1988
FIRST MEDIC MODE 610
K883584 · MKJ
First Medical Devices Corp.
Cardiovascular · 45d
Cleared Oct 06, 1988
BARD MULTI-TAC ECG MONITORING ELECTRODE
K884064 · DRX
C.R. Bard, Inc.
Cardiovascular · 10d
Cleared Oct 05, 1988
POLY-TAC
K882235 · LDD
Cardiovascular Group, Inc.
Cardiovascular · 131d
Cleared Oct 05, 1988
TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5
K882904 · DRX
Tdk Corp.
Cardiovascular · 85d
Cleared Oct 04, 1988
ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER
K881966 · DRF
C.R. Bard, Inc.
Cardiovascular · 146d
Cleared Sep 28, 1988
VASCUCARE ANGIOPUMP
K881780 · DWB
Vascucare, Inc.
Cardiovascular · 155d
Cleared Sep 28, 1988
MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH
K881825 · DYB
Spectramed, Inc.
Cardiovascular · 152d
Cleared Sep 28, 1988
ACS SCHWARTEN XT BALLOON DILATATION CATHETER
K882925 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 77d
Cleared Sep 28, 1988
ACS ANGIOSCOPE GUIDE WIRE
K883000 · LYK
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 72d
Cleared Sep 28, 1988
SARNS INFANT VENOUS RESERVOIR MODEL #16387
K883345 · DTN
3M Health Care, Sarns
Cardiovascular · 50d
Cleared Sep 27, 1988
ACS CORONARY ANGIOSCOPIC CATHETER
K875108 · LYK
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 288d
Cleared Sep 27, 1988
EXTRACORPOREAL MEMBRANE OXYGENATION CATHETER
K882771 · DWF
Cook, Inc.
Cardiovascular · 83d
Cleared Sep 27, 1988
MEMBRANE OXYGENATOR
K882892 · DTZ
Baxter Bentley Laboratories, Inc.
Cardiovascular · 78d