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
11761–11784 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 03, 1992
INTRODUCER CATHETER
K915625 · DYB
Interventional Therapeutics Corp.
Cardiovascular · 176d
Cleared Jun 03, 1992
FAST-CATH HEMOSTASIS INTRODUCER
K920779 · DYB
Daig Corp.
Cardiovascular · 104d
Cleared Jun 03, 1992
GORE TUNNELER, MODIFICATION
K920998 · DYB
W.L. Gore & Associates, Inc.
Cardiovascular · 93d
Cleared Jun 02, 1992
SILCLAMPS DEGANIA SILICONE
K920501 · DXC
Puritas Health Care, Inc.
Cardiovascular · 119d
Cleared May 28, 1992
BSM-2100A CONFIGURED PATIENT MONITOR
K914092 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 259d
Cleared May 26, 1992
BR-50-J DISPOSABLE ECG ELECTRODE
K921579 · DRX
Medicotest, Inc.
Cardiovascular · 54d
Cleared May 26, 1992
MODEL #125 CHILD STIMULATION PADS
K921606 · LDD
Cardiotronics, Inc.
Cardiovascular · 53d
Cleared May 22, 1992
MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS
K921124 · DTB
Medtronic Vascular
Cardiovascular · 102d
Cleared May 21, 1992
LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP
K921550 · KFM
St. Jude Medical, Inc.
Cardiovascular · 58d
Cleared May 20, 1992
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540-D
K914754 · DWA
Medtronic Bio-Medicus, Inc.
Cardiovascular · 211d
Cleared May 20, 1992
E-Z-FLOW ANGIOGRAPHY CATHETERS, MODIFICATION
K914984 · DQY
E-Z-Em, Inc.
Cardiovascular · 210d
Cleared May 20, 1992
GUIDE WIRES, MODIFICATION
K914986 · DQX
E-Z-Em, Inc.
Cardiovascular · 209d
Cleared May 20, 1992
HIGH PRESSURE CONNECTING SETS, MODIFICATION
K914987 · DTL
E-Z-Em, Inc.
Cardiovascular · 209d
Cleared May 15, 1992
INTERNAL MODEM FOR THE E560 ELECTROCARDIOGRAPH
K915202 · LOS
Siemens Burdick, Inc.
Cardiovascular · 179d
Cleared May 14, 1992
K-DEFIB/PACE ELECTRODE
K914955 · DRO
Katecho, Inc.
Cardiovascular · 191d
Cleared May 11, 1992
CAMBRIDGE PC/GXT STRESS TEST SYSTEM
K921331 · DPS
Health Watch, Inc.
Cardiovascular · 53d
Cleared May 08, 1992
RHYTHMSCAN PRECISION 6000
K914577 · DQK
Precision Health Care Systems, Inc.
Cardiovascular · 206d
Cleared May 06, 1992
ULTRA-THIN
K920547 · LIT
Boston Scientific Corp
Cardiovascular · 90d
Cleared May 01, 1992
VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM)
K914856 · DQY
Cook, Inc.
Cardiovascular · 185d
Cleared Apr 29, 1992
ZB-860PA MULTIPARAMETER TRANSMITTER
K913117 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 289d
Cleared Apr 28, 1992
MORTARA INSTRUMENT MODEL ECG PREVU
K920377 · LOS
Mortara Instrument, Inc.
Cardiovascular · 90d
Cleared Apr 27, 1992
ESCORT-LINK ARRHYTHMIA OPTION 23L
K915153 · DSI
Medical Data Electronics
Cardiovascular · 165d
Cleared Apr 24, 1992
INTRALUMINAL ARTERY STRIPPER
K913803 · DWX
Omni-Tract Surgical, Div. Minn....
Cardiovascular · 242d
Cleared Apr 23, 1992
AMETEC MASY MODULAR ANGIOSCOPE SYSTEM
K905745 · LYK
American Medical Technology, Inc.
Cardiovascular · 486d