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
6289–6312 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 30, 2008
MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151
K080924 · DRB
St. Jude Medical, Cardiac Rhythm...
Cardiovascular · 28d
Cleared Apr 30, 2008
EndoWave Infusion System
K080392 · QEY
Ekos Corp.
Cardiovascular · 77d
Cleared Apr 29, 2008
FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01
K080621 · DSA
European Custom Manufacturing BV
Cardiovascular · 55d
Cleared Apr 28, 2008
FOX PLUS PTA CATHETER
K080925 · LIT
Abbott Vascular, Inc.
Cardiovascular · 26d
Cleared Apr 25, 2008
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039
K080151 · PNO
Angioscore, Inc.
Cardiovascular · 94d
Cleared Apr 25, 2008
PC ECG 1200W SYSTEM
K080141 · MWI
Norav Medical , Ltd.
Cardiovascular · 94d
Cleared Apr 25, 2008
INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5
K072932 · OGZ
Infraredx, Inc.
Cardiovascular · 192d
Cleared Apr 24, 2008
ZOLL E SERIES DEFIBRILLATOR
K072923 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 192d
Cleared Apr 23, 2008
MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
K080670 · DSK
Atcor Medical
Cardiovascular · 44d
Cleared Apr 23, 2008
SEDAT MYSHELL LITE
K080472 · DTL
Sedat
Cardiovascular · 62d
Cleared Apr 23, 2008
CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02
K080425 · DRF
Biosense Webster, Inc.
Cardiovascular · 68d
Cleared Apr 23, 2008
AMBULO 2400
K080274 · DXN
Tiba Medical, Inc.
Cardiovascular · 82d
Cleared Apr 23, 2008
ZOLL E SERIES 12SL, ANALYSIS OPTION
K080232 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 84d
Cleared Apr 22, 2008
ENDOWAVE INFUSION SYSTEM
K073166 · KRA
Ekos Corp.
Cardiovascular · 165d
Cleared Apr 18, 2008
AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM
K080757 · DQY
Aga Medical Corp.
Cardiovascular · 31d
Cleared Apr 17, 2008
TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE
K080863 · DQX
MicroVention, Inc.
Cardiovascular · 20d
Cleared Apr 17, 2008
CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)
K080774 · KFM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 29d
Cleared Apr 17, 2008
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904...
K073585 · DQO
Vascular Solutions, Inc.
Cardiovascular · 119d
Cleared Apr 11, 2008
QHRV 1 - HEALTH ASSESSMENT SYSTEM
K080884 · DPS
Medtechs, LLC
Cardiovascular · 11d
Cleared Apr 11, 2008
LIFE+CEL OR LIFECEL BATTERY
K073716 · MKJ
Amco International Manufacturing &...
Cardiovascular · 102d
Cleared Apr 11, 2008
INTOUCH REMOTE PRESENCE ROBOTIC SYSTEM, MODEL RP-7
K073710 · DRG
Intouch Technologies
Cardiovascular · 102d
Cleared Apr 11, 2008
PHILIPS ECG ALGORITHM
K073376 · LOS
Philips Medical Systems
Cardiovascular · 130d
Cleared Apr 11, 2008
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
K072460 · DQX
Abbott Vascular, Inc.
Cardiovascular · 224d
Cleared Apr 10, 2008
PHYSIOFLOW SYSTEM
K060387 · DSB
Vasocom, Inc.
Cardiovascular · 786d