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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,027 results
10441–10464 of 18,027
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
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
Cleared Apr 19, 1996
G.E. STERILE ANGIOGRAPHIC TRAY
K960139 · DWS
GE Medical Systems
Cardiovascular · 94d
Cleared Apr 19, 1996
RDI CARDIAC INSULATION PAD
K960312 · DWP
R D Intl.
Cardiovascular · 88d
Cleared Apr 18, 1996
OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM
K950688 · DRT
Safety Tek Corp.
Cardiovascular · 429d
Cleared Apr 17, 1996
USCI IDEAL PTCA KIT
K953522 · MAV
Ryder Intl. Corp.
Cardiovascular · 265d
Cleared Apr 15, 1996
PLATINUM SERIES EP DIAGNOSTIC CATHETERS
K953185 · DRF
Medtronic Cardiorhythm
Cardiovascular · 280d
Cleared Apr 15, 1996
G.E. STERILE CT BIOPSY TRAY
K960144 · DWS
GE Medical Systems
Cardiovascular · 90d
Cleared Apr 15, 1996
CARBOMEDICS VALVE TESTER
K960169 · DTJ
Carbomedics, Inc.
Cardiovascular · 90d
Cleared Apr 15, 1996
NOGA
K960542 · DRF
Biosense, Ltd.
Cardiovascular · 68d
Cleared Apr 12, 1996
BRAUN HEMOSTASIS INTRODUCERS
K960406 · DYB
B.Braun Medical, Inc.
Cardiovascular · 74d
Cleared Apr 11, 1996
LMI ARTERIAL EMBOLECTOMY CATHETER
K954760 · DXE
Lucas Medical, Inc.
Cardiovascular · 177d
Cleared Apr 09, 1996
0.014 INTERMEDIATE GUIDE WIRE W/PHOSPHORYLCHOLINE POLYMER COATING
K955135 · DQX
Biocompatibles , Ltd.
Cardiovascular · 152d