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
6073–6096 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 15, 2008
SEDAT FLAMINGO
K082755 · MAV
Sedat
Cardiovascular · 87d
Cleared Dec 15, 2008
EMBOZENE MICROSPHERES
K073417 · KRD
Celonova Biosciences, Inc.
Cardiovascular · 377d
Cleared Dec 12, 2008
D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006
K083370 · QEW
Artegraft, Inc.
Cardiovascular · 28d
Cleared Dec 12, 2008
CPS AIM SL SLITTABLE INNER CATHETER
K082932 · DQY
St Jude Medical
Cardiovascular · 72d
Cleared Dec 12, 2008
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
K082382 · QEZ
Possis Medical, Inc.
Cardiovascular · 115d
Cleared Dec 12, 2008
9131 DEFIBRILLATION ELECTRODES
K082090 · MKJ
Cardiac Science Corporation
Cardiovascular · 141d
Cleared Dec 12, 2008
TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11
K081852 · DXN
Truly Instrument Limited
Cardiovascular · 165d
Cleared Dec 11, 2008
SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER
K082559 · DQY
Spectranetics Corp.
Cardiovascular · 98d
Cleared Dec 11, 2008
CHAPERON GUIDING CATHETER
K082385 · DQY
MicroVention, Inc.
Cardiovascular · 114d
Cleared Dec 11, 2008
BIONET BM3PLUS PATIENT MONITOR
K082008 · MWI
Bionet Co., Ltd.
Cardiovascular · 149d
Cleared Dec 10, 2008
SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS
K082561 · DQY
Spectranetics Corp.
Cardiovascular · 97d
Cleared Dec 09, 2008
FREEWAY AND RAILRUNNER GUIDEWIRES
K082922 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 69d
Cleared Dec 09, 2008
MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
K082308 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 118d
Cleared Dec 09, 2008
ZOLL R SERIES BLS DEFIBRILLATOR
K081828 · MKJ
ZOLL Medical Corporation
Cardiovascular · 165d
Cleared Dec 09, 2008
AGILIS NXT STEERABLE INTRODUCER, MODEL G408324
K081645 · DYB
St Jude Medical
Cardiovascular · 180d
Cleared Dec 09, 2008
ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE...
K080428 · DQY
Medtronic, Inc.
Cardiovascular · 294d
Cleared Dec 08, 2008
SPECTRA GUIDEWIRE INTRODUCER NEEDLE
K082580 · DYB
Spectra Medical Devices, Inc.
Cardiovascular · 94d
Cleared Dec 04, 2008
HEADWAY 17 MICROCATHETER
K083343 · DQY
MicroVention, Inc.
Cardiovascular · 21d
Cleared Dec 04, 2008
VISION WIRE CORONARY GUIDEWIRE
K082935 · DQX
Biotronik, Inc.
Cardiovascular · 64d
Cleared Dec 04, 2008
NANOCORSS .014 OTW PTA DILATATION CATHETER
K082854 · DQY
Ev3, Inc.
Cardiovascular · 66d
Cleared Dec 04, 2008
MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET
K082670 · DQY
Medtronic, Inc.
Cardiovascular · 80d
Cleared Dec 04, 2008
THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006
K081697 · DYB
Access Scientific, Inc.
Cardiovascular · 170d
Cleared Dec 04, 2008
ZOLL E SERIES WITH INTIBATION ASSIST OPTION
K080903 · MKJ
ZOLL Medical Corporation
Cardiovascular · 247d
Cleared Dec 03, 2008
VICARDIO 12B
K082380 · DPS
Energy-Lab Technologies GmbH
Cardiovascular · 106d