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
14281–14304 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 25, 1986
[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP
K862056 · DQY
Arrow Intl., Inc.
Cardiovascular · 87d
Cleared Aug 25, 1986
MODIFICATIONS TO CORDIS' SUPER FLOW CATHETERS
K862244 · DQO
Cordis Corp.
Cardiovascular · 74d
Cleared Aug 25, 1986
MINI-HOLTER, MODEL 2000
K862526 · DSH
Holter Recorders
Cardiovascular · 54d
Cleared Aug 25, 1986
MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION
K862748 · DPS
Cambridge Medical Instruments, Inc.
Cardiovascular · 35d
Cleared Aug 25, 1986
CLASSIC RESTING SILVER-SILVERCHLORIDE ELECTRODE
K862953 · DRY
Classic Medical Products, Inc.
Cardiovascular · 20d
Cleared Aug 21, 1986
INTERVASCULAR OCHSNER MICRON VASCULAR PROSTHESES
K862739 · DSY
Intervascular, Inc.
Cardiovascular · 31d
Cleared Aug 19, 1986
SEAMED MODEL 3000
K860462 · DTC
Seamed Corp.
Cardiovascular · 194d
Cleared Aug 19, 1986
MODIFICATION OF TISSUE DILATOR
K862288 · DRE
Quinton, Inc.
Cardiovascular · 64d
Cleared Aug 19, 1986
MODIFIED CARDIOTOMY RESERVOIR 5M1470
K862357 · DTN
3M Health Care, Sarns
Cardiovascular · 57d
Cleared Aug 19, 1986
ASTRA 2,3,4 AND 6: CHIP REVISION
K863000
Cardiac Pacemakers, Inc.
Cardiovascular · 11d
Cleared Aug 18, 1986
INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR
K854845 · DSY
Intervascular, Inc.
Cardiovascular · 257d
Cleared Aug 18, 1986
MODEL SP1465 CARDIAC OUTPUT COMPUTER
K861092 · DXG
Gould, Inc.
Cardiovascular · 147d
Cleared Aug 18, 1986
PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403
K862647 · DSK
Ivy Biomedical Systems, Inc.
Cardiovascular · 38d
Cleared Aug 18, 1986
SPECTRUM POLYCORD I RECORDER SYSTEM
K862776 · DSH
Cardionics, Inc.
Cardiovascular · 27d
Cleared Aug 14, 1986
AMBULATORY BLOOD PRESSURE MONITOR SPACELABS #90202
K855127 · DXN
Spacelabs, Inc.
Cardiovascular · 234d
Cleared Aug 14, 1986
DIFFERENTIAL STETHOSCOPE W/DUAL HEADS
K860473 · LDE
Schering Corp.
Cardiovascular · 189d
Cleared Aug 11, 1986
SCHNEIDER-SHILEY OCCLUDER/FLUSHING CATH. STOPCOCK
K862465 · DQO
Shiley, Inc.
Cardiovascular · 42d
Cleared Aug 11, 1986
SCHNEIDER-SHILEY SELDINGER INITIAL PUNCTURE INSTR
K862467 · LIT
Shiley, Inc.
Cardiovascular · 42d
Cleared Aug 08, 1986
NEOS VS-1, PULSE GENERATOR
K860921 · DXY
Biotronik Sales, Inc.
Cardiovascular · 150d
Cleared Aug 08, 1986
POLY-TECH ANGIOGRAPHY CATHETER
K862030 · DQO
Poly-Tech Medical Device Research &...
Cardiovascular · 72d
Cleared Aug 08, 1986
GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON)
K862068 · DTM
Gelman Sciences, Inc.
Cardiovascular · 70d
Cleared Aug 08, 1986
MODIFIED OSCOR PY PACING LEADS
K862330 · DTB
Oscor Medical Corp.
Cardiovascular · 50d
Cleared Aug 06, 1986
GEREONICS BIOPOTENTIAL SKIN ELECTRODES
K861099 · DRX
Gereonics, Inc.
Cardiovascular · 135d
Cleared Aug 06, 1986
PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD
K861246 · DRX
Conmedcorp
Cardiovascular · 132d