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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,151 results
11593–11616 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 06, 1993
BARD WILLIAM HARVEY AORTIC ROOT CARDIOPLEGIA CANNU
K930593 · DWF
C.R. Bard, Inc.
Cardiovascular · 91d
Cleared Apr 30, 1993
ITC CATHETERS W/ HYDROMER
K922609 · DQY
Interventional Therapeutics Corp.
Cardiovascular · 332d
Cleared Apr 30, 1993
EP AMP, MODEL #901
K925346 · DRR
Quinton Electrophysiology Corp.
Cardiovascular · 190d
Cleared Apr 30, 1993
BALANCED(TM) NYLON BLADDER
K930604 · DXQ
Pymah Corp.
Cardiovascular · 84d
Cleared Apr 29, 1993
CARDIFIX ENDOCARDIAL PACING LEAD
K922042 · DTB
Intermedics, Inc.
Cardiovascular · 363d
Cleared Apr 29, 1993
AMPLATZ GUIDEWIRES
K930622 · DQX
Meadox Medicals, Div. Boston...
Cardiovascular · 80d
Cleared Apr 27, 1993
SYSTEM 97
K922235 · DSP
Datascope Corp.
Cardiovascular · 349d
Cleared Apr 27, 1993
THE ACTA FORMULA
K922703 · DPS
Biosound, Inc.
Cardiovascular · 326d
Cleared Apr 27, 1993
MORTARA INSTRUMENT, INC. E-SCRIBE
K930558 · DPS
Mortara Instrument, Inc.
Cardiovascular · 83d
Cleared Apr 22, 1993
ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET
K924607 · DYB
Arrow Intl., Inc.
Cardiovascular · 223d
Cleared Apr 21, 1993
SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM
K922221 · LOS
Del Mar Avionics
Cardiovascular · 344d
Cleared Apr 21, 1993
NYLEX CATHETERS
K930479 · DQO
Cordis Corp.
Cardiovascular · 82d
Cleared Apr 20, 1993
PLEUR-EVAC CARDIOTOMY RESERVOIR
K925046 · DTN
Deknatel, Inc.
Cardiovascular · 196d
Cleared Apr 16, 1993
TRACET T-6000
K930258 · DRX
Lectec Corp.
Cardiovascular · 87d
Cleared Apr 15, 1993
K-DEFIB/PACE CARBON ELECTRODE
K926175 · DRO
Katecho, Inc.
Cardiovascular · 128d
Cleared Apr 09, 1993
9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT
K930134 · DPS
S & W Medico Teknik
Cardiovascular · 87d
Cleared Apr 08, 1993
SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER
K924661 · KRA
Baxter Healthcare Corp
Cardiovascular · 205d
Cleared Apr 08, 1993
SCIMED(R) 0.038 CONTROLWIRE(TM) PERIPHER GUIDE WIR
K926457 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 105d
Cleared Apr 07, 1993
MAGIC INFUSION CATHETER
K923368 · KRA
Target Therapeutics
Cardiovascular · 272d
Cleared Apr 07, 1993
BARD(R) INTRA AORTIC BALLOON
K924382 · DSP
C.R. Bard, Inc.
Cardiovascular · 219d
Cleared Apr 07, 1993
CORDIS REFLEX STEERABLE GUIDEWIRE
K930091 · DQX
Cordis Corp.
Cardiovascular · 89d
Cleared Apr 06, 1993
GISH ARTERIAL FILTER
K914791 · DTM
Gish Biomedical, Inc.
Cardiovascular · 531d
Cleared Apr 01, 1993
HEWLETT-PACKARD MODEL 78730 CAREVUE 5000
K922210 · MHX
Hewlett-Packard Co.
Cardiovascular · 324d
Cleared Mar 26, 1993
MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER
K924642 · DWF
Medtronic Bio-Medicus, Inc.
Cardiovascular · 193d