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
13825–13848 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 18, 1987
CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM
K872034 · DRN
Cardiomedics, Inc.
Cardiovascular · 114d
Cleared Sep 18, 1987
MODIFIED VERSA STIM ELECTRODE LINE
K872368 · DRO
Conmedcorp
Cardiovascular · 92d
Cleared Sep 16, 1987
CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS
K871573 · DQY
Spectramed, Inc.
Cardiovascular · 147d
Cleared Sep 15, 1987
HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR.
K871271 · DRM
Huntleigh Technology, Inc.
Cardiovascular · 168d
Cleared Sep 15, 1987
LAKE REGION VARIABLE STIFFNESS GUIDEWIRE (VSGW)
K871882 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 127d
Cleared Sep 15, 1987
COLIN'S MODEL APBM-630 AND QUINTON'S MODEL 470
K872355 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 89d
Cleared Sep 15, 1987
THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2
K872529 · DXG
American Edwards Laboratories
Cardiovascular · 81d
Cleared Sep 15, 1987
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER/ UA-741
K872629 · DXN
A&D Engineering, Inc.
Cardiovascular · 71d
Cleared Sep 15, 1987
SHEATH/DILATORS
K872724 · DRE
Med-West, Inc.
Cardiovascular · 69d
Cleared Sep 15, 1987
PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860
K872731 · DTB
Ela Medical, Inc.
Cardiovascular · 69d
Cleared Sep 15, 1987
PERFUSION CATHETER
K872790 · DQT
Bd Becton Dickinson Vacutainer...
Cardiovascular · 63d
Cleared Sep 15, 1987
GUIDING CATHETER
K873004 · DQO
Mallinckrodt Critical Care
Cardiovascular · 42d
Cleared Sep 14, 1987
AIS ANGIOSCOPE
K871492 · DQX
Advanced Interventional Systems, Inc.
Cardiovascular · 151d
Cleared Sep 14, 1987
WILLIAM HARVEY HARDSHELL VENOUS RESERVOIR
K872378 · DTN
C.R. Bard, Inc.
Cardiovascular · 87d
Cleared Sep 14, 1987
SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE
K872472 · DXT
Angiomedics, Inc.
Cardiovascular · 83d
Cleared Sep 14, 1987
SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETER
K872542 · LIT
Angiomedics, Inc.
Cardiovascular · 77d
Cleared Sep 08, 1987
MOD 482
K870850 · JOP
Hoffrel Instruments, Inc.
Cardiovascular · 189d
Cleared Sep 04, 1987
MULTIPLE
K863387 · DXK
Del Mar Avionics
Cardiovascular · 366d
Cleared Sep 01, 1987
CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100
K870804 · DTR
American Bentley
Cardiovascular · 186d
Cleared Sep 01, 1987
HOLTER ST SYSTEM, MODEL NO. 5000-20
K871389 · DSI
Holter Data Services
Cardiovascular · 147d
Cleared Sep 01, 1987
CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500
K872167 · DTP
American Bentley
Cardiovascular · 85d
Cleared Aug 28, 1987
WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
K872107 · DTZ
Minntech Corp.
Cardiovascular · 80d
Cleared Aug 27, 1987
CORONARY ARTERY BYPASS GRAFT (CABG) MARKER
K871110 · DSY
Edward Weck, Inc.
Cardiovascular · 161d
Cleared Aug 25, 1987
5 MHZ TRANSDUCER
K872074 · JOP
Sonicaid, Inc.
Cardiovascular · 88d