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
14401–14424 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 02, 1986
INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER
K860121 · DPT
NuMED, Inc.
Cardiovascular · 140d
Cleared Jun 02, 1986
INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70
K861226 · KRJ
Medical, Inc.
Cardiovascular · 62d
Cleared Jun 02, 1986
CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000
K861277 · DRY
Critichem, Inc.
Cardiovascular · 56d
Cleared May 30, 1986
GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200
K860076 · DTW
Gambro, Inc.
Cardiovascular · 142d
Cleared May 30, 1986
STOCKERT-SHILEY AORTIC ROOT CANNULAE
K861310 · DWF
Shiley, Inc.
Cardiovascular · 52d
Cleared May 30, 1986
RMI POROUS VENT PLUG
K861322 · DWF
Research Medical, Inc.
Cardiovascular · 52d
Cleared May 30, 1986
ACS WHOLEY HI-TORQUE GUIDE WIRE
K861765 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 23d
Cleared May 28, 1986
CAROTID BALLOON SHUNT
K860497 · DWF
Imodex, Inc.
Cardiovascular · 107d
Cleared May 28, 1986
IMPLANT PROG PULSE GENERATOR, UNIPOLAR & BIPOLAR
K860573 · DXY
Telectronics, Inc.
Cardiovascular · 103d
Cleared May 28, 1986
SARNS FILTERED CARDIOTOMY RESERVOIR
K860702 · DTP
3M Health Care, Sarns
Cardiovascular · 92d
Cleared May 28, 1986
CAROTID BYPASS SHUNT
K860742 · DWF
Clincal Instruments Corp.
Cardiovascular · 90d
Cleared May 28, 1986
CAROTID BYPASS SHUNT WITH SAMPLING ARM
K860743 · DWF
Clincal Instruments Corp.
Cardiovascular · 90d
Cleared May 28, 1986
MEDIASTINAL AUTOTRANSFUSION SYSTEM
K860775 · DTP
Cardio Metrics, Inc.
Cardiovascular · 86d
Cleared May 28, 1986
CPS-3000 CARDIOPLEGIA RESERVOIR
K861102 · DTR
Gish Biomedical, Inc.
Cardiovascular · 65d
Cleared May 28, 1986
CHEST DRAINAGE PACK, CDP-1000
K861103 · DWF
Gish Biomedical, Inc.
Cardiovascular · 65d
Cleared May 28, 1986
TORAY ANTHRON BYPASS TUBES
K861116 · DWF
Toray Industries (America), Inc.
Cardiovascular · 64d
Cleared May 28, 1986
CAPIOX III CARDIOPULMONARY BYPASS OXYGENATOR
K861177 · DTZ
Terumo Medical Corp.
Cardiovascular · 58d
Cleared May 28, 1986
ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRE
K861574 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 30d
Cleared May 28, 1986
SCHNEIDER-SHILEY PRESSURE MANOMETER
K861605 · KRK
Shiley, Inc.
Cardiovascular · 29d
Cleared May 27, 1986
STOCKERT-SHILEY VENOUS CATH & AORTIC ARCH CANNULA
K861496 · DWF
Shiley, Inc.
Cardiovascular · 35d
Cleared May 21, 1986
STOCKERT-SHILEY HEATER/COOLER TEMPERATURE CONTROL
K860920 · DTR
Shiley, Inc.
Cardiovascular · 71d
Cleared May 21, 1986
PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III
K860980 · DSI
Spacelabs, Inc.
Cardiovascular · 71d
Cleared May 21, 1986
RMI CAROTID BY-PASS SHUNT
K860988 · DWF
Research Medical, Inc.
Cardiovascular · 65d
Cleared May 21, 1986
CARDIOPULMONARY CANNULA TUBING
K861096 · DWF
Bio Medicus, Inc.
Cardiovascular · 58d