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
4777–4800 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 24, 2012
CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO...
K120086 · DRA
Cardiosolutions
Cardiovascular · 104d
Cleared Apr 20, 2012
MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM)...
K120868 · DSP
Datascope Corp., Cardiac Assist Division
Cardiovascular · 29d
Cleared Apr 20, 2012
GORE DRYSEAL SHEATH
K120428 · DYB
W.L. Gore & Associates, Inc.
Cardiovascular · 67d
Cleared Apr 20, 2012
EXCELSIOR XT-27 MICROCATHETER
K113778 · DQY
Stryker Neurovascular
Cardiovascular · 120d
Cleared Apr 19, 2012
ATLAS PTA BALLOON DILATATION CATHETER
K120971 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 17d
Cleared Apr 19, 2012
WHOLEY GUIDE WIRE SYSTEM
K120863 · DQX
Covidien, LLC
Cardiovascular · 28d
Cleared Apr 19, 2012
RIVAL PTA DILATATION CATHETER
K120722 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 41d
Cleared Apr 18, 2012
MANTARAY GUIDEWIRES
K120881 · DQX
Bridgepoint Medical
Cardiovascular · 26d
Cleared Apr 17, 2012
COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002)
K121001 · JOW
Novitas Medical, LLC
Cardiovascular · 15d
Cleared Apr 17, 2012
INZONE DETACHMENT SYSTEM
K120816 · KRD
Stryker
Cardiovascular · 29d
Cleared Apr 13, 2012
FLEXITOUCH SYSTEM
K120972 · JOW
Tactile Systems Technology, Inc.
Cardiovascular · 11d
Cleared Apr 13, 2012
PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
K120805 · LIT
Angioslide, Ltd.
Cardiovascular · 28d
Cleared Apr 12, 2012
TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH...
K112398 · DYB
Galt Medical
Cardiovascular · 237d
Cleared Apr 10, 2012
ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE...
K120774 · DSI
Welch Allyn, Inc.
Cardiovascular · 27d
Cleared Apr 09, 2012
SONIXGPS VASCULAR ACCESS NEEDLE KIT
K120349 · DRE
Ultrasonix Medical Corpation
Cardiovascular · 63d
Cleared Apr 05, 2012
INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY...
K113626 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 119d
Cleared Apr 03, 2012
ENCORE 26 ADVANTAGE KIT
K120694 · MAV
Boston Scientific Corp
Cardiovascular · 27d
Cleared Apr 03, 2012
REPROCESSED FEMORAL COMPRESSION DEVICE
K120204 · NMF
Sterilmed, Inc.
Cardiovascular · 71d
Cleared Apr 03, 2012
MEDLINE STOPCOCK AND MANIFOLD
K120069 · DTL
Medline Industries, Inc.
Cardiovascular · 85d
Cleared Apr 03, 2012
PAGEWRITER TC 20, 30, 50, 70
K113144 · DPS
Philips Medical Systems
Cardiovascular · 161d
Cleared Mar 30, 2012
KITTYCAT CATHETER, KITTYCAT 2 CATHETER
K120273 · PDU
Avinger, Inc.
Cardiovascular · 60d
Cleared Mar 30, 2012
ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS
K112452 · DQO
AngioDynamics, Inc.
Cardiovascular · 218d
Cleared Mar 30, 2012
CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R)...
K112119 · DTK
William Cook Europe Aps
Cardiovascular · 249d
Cleared Mar 29, 2012
IMAGER II ANGIOGRAPHIC CATHETERS
K120893 · DQO
Boston Scientific Corp
Cardiovascular · 6d