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
13201–13224 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 01, 1989
MVL/MODULAB WITH PVR MODULE
K884624 · JOM
Life Sciences Manufacturing, Inc.
Cardiovascular · 89d
Cleared Jan 30, 1989
DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K884872 · DTN
Shiley, Inc.
Cardiovascular · 70d
Cleared Jan 30, 1989
CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25
K884893 · KRI
American Omni Medical, Inc.
Cardiovascular · 69d
Cleared Jan 30, 1989
MODEL 6208,6209,6210,6211,6212,6214 (PLI'S)
K890045 · DTB
Medtronic Vascular
Cardiovascular · 25d
Cleared Jan 26, 1989
ANGIOSCOPE FOR PULMONARY ARTERY USE
K882658 · DQO
Washington Regulatory Services
Cardiovascular · 211d
Cleared Jan 26, 1989
OPTIMA MPT AND SPT PACEMAKERS
K884411 · DXY
Telectronics, Inc.
Cardiovascular · 98d
Cleared Jan 25, 1989
UNILITH 3 MODELS 7580/7583/7680/7683
K883037 · DXY
Ela Medical, Inc.
Cardiovascular · 190d
Cleared Jan 25, 1989
MC6700 MULTI-CHANNEL ELECTROCARDIOGRAPH
K883454 · DPS
Cambridge Medical Instruments, Inc.
Cardiovascular · 163d
Cleared Jan 25, 1989
SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.
K885235 · DSK
Spectramed, Inc.
Cardiovascular · 36d
Cleared Jan 25, 1989
POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES
K885262 · DRX
Valleylab, Inc.
Cardiovascular · 33d
Cleared Jan 25, 1989
MINIFLOW DISPOSABLE PRESSURE TRANSDUCER 63-600F
K885296 · DRS
Baxter Healthcare Corp
Cardiovascular · 29d
Cleared Jan 24, 1989
SOFTRAC-PTA PERIPHERAL DILATATION CATHETER
K882826 · LIT
Schneider-Shilley (Usa)
Cardiovascular · 200d
Cleared Jan 24, 1989
CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700
K884640 · KRI
American Omni Medical, Inc.
Cardiovascular · 78d
Cleared Jan 24, 1989
SARNS 9000 WITH CENTRIFUGAL PUMP OPTION
K884659 · KFM
3M Health Care, Sarns
Cardiovascular · 78d
Cleared Jan 24, 1989
BARD TAB ECG MONITORING ELECTRODE
K890103 · DRX
C.R. Bard, Inc.
Cardiovascular · 14d
Cleared Jan 19, 1989
MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM
K882609 · DRT
Waltham Div. Hewlett Packard
Cardiovascular · 206d
Cleared Jan 18, 1989
USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER
K884502 · DQO
C.R. Bard, Inc.
Cardiovascular · 84d
Cleared Jan 17, 1989
TAKEDA MEDICAL AUTO. DIGITAL BLOOD PRES. MONITOR
K882824 · DXN
A&D Engineering, Inc.
Cardiovascular · 193d
Cleared Jan 17, 1989
TAKEDA MEDICAL AUTO. DIG. BLOOD PRES. METER W/PRIN
K882825 · DXN
A&D Engineering, Inc.
Cardiovascular · 193d
Cleared Jan 17, 1989
MINIMON 7134B PATIENT MONITOR
K883069 · DRT
Kontron Instruments, Inc.
Cardiovascular · 181d
Cleared Jan 17, 1989
MINIMON 7136B PATIENT MONITOR
K883109 · DRT
Kontron, Inc.
Cardiovascular · 176d
Cleared Jan 17, 1989
EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER)
K883402 · DPS
Quinton, Inc.
Cardiovascular · 166d
Cleared Jan 17, 1989
E550 ELECTROCARDIOGRAPH
K883440 · DSI
Burdick Corp.
Cardiovascular · 155d
Cleared Jan 17, 1989
MEDTRONIC MODEL 4058 PACING LEAD
K883743 · DTB
Medtronic Vascular
Cardiovascular · 138d