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
4729–4752 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 08, 2012
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA...
K121402 · LIT
Trireme Medical, Inc.
Cardiovascular · 29d
Cleared Jun 08, 2012
ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
K120624 · DRS
Elcam Medical Acal
Cardiovascular · 99d
Cleared Jun 08, 2012
MIPAL
K120470 · DRG
Watermark Medical
Cardiovascular · 113d
Cleared Jun 08, 2012
PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
K120164 · LIT
Angioslide, Ltd.
Cardiovascular · 141d
Cleared Jun 07, 2012
EXPORT XT CATHETER, EXPORT AP CATHETER
K120808 · QEZ
Medtronic, Inc.
Cardiovascular · 83d
Cleared Jun 06, 2012
ARIATELE TELEMETRY TRANSMITTER (96281)
K121480 · MHX
Spacelabs Healthcare
Cardiovascular · 19d
Cleared Jun 06, 2012
DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF
K120987 · DWF
Medtronic, Inc.
Cardiovascular · 65d
Cleared Jun 06, 2012
ANGIOJET SOLENT DISTA THROMBECTOMY SET
K113363 · QEZ
Medrad, Inc.
Cardiovascular · 204d
Cleared Jun 01, 2012
KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR
K120672 · DXN
Andon Health Co, Ltd.
Cardiovascular · 88d
Cleared Jun 01, 2012
CLEANER ROTATIONAL THROMBECTOMY SYSTEM
K120346 · MCW
Rex Medical
Cardiovascular · 119d
Cleared May 31, 2012
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
K120944 · JOW
Covidien
Cardiovascular · 63d
Cleared May 30, 2012
TANDEMHEART FEMORAL ARTERIAL CANNULA SET
K120543 · DWF
Cardiacassist, Inc.
Cardiovascular · 97d
Cleared May 30, 2012
SOLOHEALTH STATION
K113402 · DXN
Solohealth, Inc.
Cardiovascular · 195d
Cleared May 29, 2012
HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER
K111004 · DXX
Hansen Medical, Inc.
Cardiovascular · 414d
Cleared May 25, 2012
UPSTREAM GR CATHETER
K120964 · DQY
Upstream Peripheral Technologies
Cardiovascular · 56d
Cleared May 25, 2012
PATIENT MONITOR
K120631 · MHX
Advanced Instruments, Inc.
Cardiovascular · 85d
Cleared May 25, 2012
MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT
K120612 · DWF
Medtronic, Inc.
Cardiovascular · 86d
Cleared May 24, 2012
REMOTE PRESENCE SYSTEM
K120895 · DRG
Intouch Health, Inc.
Cardiovascular · 62d
Cleared May 24, 2012
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
K120425 · MTD
Biosense Webster, Inc.
Cardiovascular · 101d
Cleared May 22, 2012
AMPHIRION PLUS PTA CATHETER
K121265 · LIT
Medtronic, Inc.
Cardiovascular · 26d
Cleared May 22, 2012
BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES
K120533 · PDU
Bridgepoint Medical
Cardiovascular · 90d
Cleared May 22, 2012
SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE
K113103 · PNO
Rex Medical
Cardiovascular · 216d
Cleared May 21, 2012
IMPULSE AND EXPO ANGIOGRAPHIC CATHETER
K120495 · DQO
Boston Scientific Corp
Cardiovascular · 94d
Cleared May 17, 2012
HEARTCHECK ECG PEN WITH GEMS HOME
K121009 · DPS
Cardiocomm Solutions, Inc.
Cardiovascular · 44d