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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
13273–13296 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 13, 1988
HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT
K882657 · DYB
Harbor Medical Devices, Inc.
Cardiovascular · 167d
Cleared Dec 13, 1988
TARGET THERAPEUTICS SEEKER-16 STEERABLE GUIDEWIRE
K884198 · DQX
Target Therapeutics
Cardiovascular · 68d
Cleared Dec 13, 1988
THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM
K884318 · KRB
Abbott Laboratories
Cardiovascular · 61d
Cleared Dec 12, 1988
ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.
K882289 · DSY
Aries Medical, Inc.
Cardiovascular · 194d
Cleared Dec 12, 1988
CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.
K883888 · DXK
Advanced Biosearch Assn.
Cardiovascular · 88d
Cleared Dec 08, 1988
PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F
K884394 · DTB
Ela Medical, Inc.
Cardiovascular · 55d
Cleared Dec 05, 1988
SYSTEM VI MONITOR
K874326 · DPS
Air-Shields, Inc.
Cardiovascular · 411d
Cleared Dec 05, 1988
POLYCORD II
K880303 · DSH
Technetics, Inc.
Cardiovascular · 315d
Cleared Dec 05, 1988
BLOOD RESERVOIR, CARDIOPULMONARY BYPASS
K882414 · DTN
Gish Biomedical, Inc.
Cardiovascular · 175d
Cleared Dec 05, 1988
ENCOR UNIPOLAR VS-1 LEADS
K883070 · DTB
Cordis Leads, Inc.
Cardiovascular · 138d
Cleared Dec 05, 1988
SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM
K883071 · DTR
3M Health Care, Sarns
Cardiovascular · 138d
Cleared Dec 05, 1988
FLEXIBLE MYOCARDIAL BIOPSY FORCEPS
K883723 · DWZ
Cook, Inc.
Cardiovascular · 96d
Cleared Dec 05, 1988
ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED
K884005 · DTB
Medtronic Vascular
Cardiovascular · 75d
Cleared Dec 05, 1988
USCI TANDEM ADAPTER
K884200 · DTL
C.R. Bard, Inc.
Cardiovascular · 60d
Cleared Dec 05, 1988
INTERSEPT* PREBYPASS FILTER
K884244 · KRJ
Medtronic Blood Systems, Inc.
Cardiovascular · 55d
Cleared Dec 02, 1988
INTRODUCING CATHETER
K883933 · DYB
Devices For Vascular Intervention, Inc.
Cardiovascular · 78d
Cleared Dec 01, 1988
EXCEL INFLATE-AID
K883769 · DXT
Medical Profiles, Inc.
Cardiovascular · 86d
Cleared Nov 30, 1988
FLO-RESTER
K883696 · DXC
Bio-Vascular, Inc.
Cardiovascular · 92d
Cleared Nov 29, 1988
TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER
K881303 · DPT
Triton Technology, Inc.
Cardiovascular · 246d
Cleared Nov 29, 1988
TRANSESOPHAGEAL ECHO TRANSDUCER
K883889 · JOP
General Electric Co.
Cardiovascular · 76d
Cleared Nov 28, 1988
MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES
K882383 · DWZ
CIVCO Medical Instruments Co., Inc.
Cardiovascular · 172d
Cleared Nov 23, 1988
ULTRASONIC IMAGING CATHETER
K883202 · DXO
Boston Scientific Corp
Cardiovascular · 118d
Cleared Nov 18, 1988
MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCER
K883651 · DQO
Millar Instruments, Inc.
Cardiovascular · 84d
Cleared Nov 18, 1988
TRIAD-EP II, PUSHBUTTON, CABLE INPUT
K884532 · DRO
Cardiotronics, Inc.
Cardiovascular · 21d