FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
10513–10536 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 14, 1996
IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4)
K955379 · DRY
International Biophysics Corp.
Cardiovascular · 172d
Cleared May 14, 1996
IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)
K955380 · DRY
International Biophysics Corp.
Cardiovascular · 172d
Cleared May 13, 1996
CARDIOSMART
K950989 · DPS
Hellige GmbH
Cardiovascular · 437d
Cleared May 13, 1996
PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET
K961513 · DYB
Ep Medsystems
Cardiovascular · 24d
Cleared May 10, 1996
HEARTPORT ENDOARTERIAL RETURN CANNUAL
K955121 · DWF
Heartport, Inc.
Cardiovascular · 183d
Cleared May 08, 1996
M.I.C.
K950967 · JOW
V.V.T. Healthcare Technologies, Inc.
Cardiovascular · 447d
Cleared May 08, 1996
INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR...
K961471 · MAV
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 21d
Cleared May 07, 1996
CODEMASTER XL + XL W/SHOCK ADVISORY OPTION
K954957 · MKJ
Hewlett-Packard Co.
Cardiovascular · 193d
Cleared May 02, 1996
RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY
K955684 · DXT
Contour Fabricators of Florida, Inc.
Cardiovascular · 140d
Cleared May 02, 1996
TURBO TRACKER
K960806 · DQO
Target Therapeutics
Cardiovascular · 64d
Cleared Apr 30, 1996
INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F)
K961135 · DYB
C.R. Bard, Inc.
Cardiovascular · 40d
Cleared Apr 29, 1996
RAILWIRE
K954552 · DQX
Boston Scientific /International...
Cardiovascular · 210d
Cleared Apr 29, 1996
IVT 0.014 TRACK OR IVT 0.014 ACCUTRACK
K954622 · DQX
Boston Scientific /International...
Cardiovascular · 207d
Cleared Apr 29, 1996
SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES
K960563 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 80d
Cleared Apr 29, 1996
SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE
K960657 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 73d
Cleared Apr 29, 1996
CARBOMEDICS MITRAL ROTATOR
K960923 · MOP
Carbomedics, Inc.
Cardiovascular · 54d
Cleared Apr 25, 1996
ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE
K960379 · MCW
Heart Technology Mfg., Inc.
Cardiovascular · 90d
Cleared Apr 25, 1996
VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT
K960706 · DSY
Carbomedics, Inc.
Cardiovascular · 64d
Cleared Apr 24, 1996
PERCOR STAT-DL 9.5 FR. 34 & 40CC
K960166 · DSP
Datascope Corp.
Cardiovascular · 99d
Cleared Apr 23, 1996
ECLIPSE 4 ELECTROCARDIOGRAPH
K946281 · LOS
Burdick, Inc.
Cardiovascular · 483d
Cleared Apr 22, 1996
SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT
K952879 · KFM
Baxter Healthcare Corp
Cardiovascular · 304d
Cleared Apr 22, 1996
PACETRAK PLUS
K954495 · DXH
Universal Medical, Inc.
Cardiovascular · 208d
Cleared Apr 19, 1996
SARNS 800 ROLLER PUMP
K953901 · DWB
3M Health Care, Sarns
Cardiovascular · 245d
Cleared Apr 19, 1996
SARNS 9000 UNIVERSAL ROLLER PUMP
K953904 · DWB
3M Health Care, Ltd.
Cardiovascular · 245d