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
10105–10128 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 18, 1997
PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS
K971010 · LIT
Cordis Corp.
Cardiovascular · 90d
Cleared Jun 18, 1997
FOCUS-PV BALLOON DILATATION CATHETER
K971577 · LIT
Cardiovascular Dynamics, Inc.
Cardiovascular · 58d
Cleared Jun 17, 1997
8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER,
K963920 · DSP
Arrow Intl., Inc.
Cardiovascular · 260d
Cleared Jun 17, 1997
HEARTPORT ENDOARTERIAL RETURN CANNULA
K971291 · DWF
Heartport, Inc.
Cardiovascular · 71d
Cleared Jun 11, 1997
3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES
K971444 · DRX
3M Medical Products Group
Cardiovascular · 51d
Cleared Jun 10, 1997
HOTMAN
K952172 · DSB
Hemo Sapiens, Inc.
Cardiovascular · 764d
Cleared Jun 10, 1997
CLYDE CORONARY GUIDEWIRE
K970528 · DQX
Schneider (Europe) GmbH
Cardiovascular · 119d
Cleared Jun 06, 1997
PTCA GUIDEWIRE
K970376 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 123d
Cleared Jun 05, 1997
INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
K970843 · DSY
Intervascular, Inc.
Cardiovascular · 90d
Cleared Jun 04, 1997
SIEMENS SC9000/SC9015 MULTIGAS AND MULTIGAS+ MODULES
K965062 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 168d
Cleared Jun 04, 1997
FOGARTY VALVULOTOME MODEL 700091
K965137 · MGZ
Baxter Edwards
Cardiovascular · 163d
Cleared Jun 04, 1997
PACE 101H
K970497 · DTE
Sulzer Oscor, Inc.
Cardiovascular · 114d
Cleared Jun 03, 1997
SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER
K970823 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 89d
Cleared May 28, 1997
ULTRAVERSE PTA CATHETER
K964881 · LIT
Vas-Cath, Inc.
Cardiovascular · 174d
Cleared May 28, 1997
Cordis Endeavor Infusion Catheter
K970842 · QEY
Cordis Corp.
Cardiovascular · 82d
Cleared May 28, 1997
USCI MAINSTAY GUIDING CATHETER
K971034 · DQO
C.R. Bard, Inc.
Cardiovascular · 68d
Not Cleared May 23, 1997
STELA MODEL BJ44 AND BJ45 PACING LEADS
K963738 · DTB
Ela Medical, Inc.
Cardiovascular · 248d
Cleared May 23, 1997
OCCLUSION CLAMP** DEVICE
K964251 · DXC
United States Surgical, A Division of...
Cardiovascular · 211d
Cleared May 21, 1997
CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE...
K964551 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 189d
Cleared May 20, 1997
ZOLL AUTOCLAVABLE INTERNAL HANDLES
K963781 · LDD
Zoll Medical Corp
Cardiovascular · 242d
Cleared May 20, 1997
2.9F CRAGG-MCNAMARA VALVED INFUSION CATHETER
K964868 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 167d
Cleared May 20, 1997
RADIUS PTCA GUIDEWIRE
K970466 · LIT
Radius Medical Technologies, Inc.
Cardiovascular · 102d
Cleared May 20, 1997
LOCKING STYLET 2
K970690 · DQX
Cook Pacemaker Corp.
Cardiovascular · 84d
Cleared May 16, 1997
MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING
K953647 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 651d