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
13321–13344 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 03, 1988
ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLES
K883564 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 73d
Cleared Nov 03, 1988
SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
K883603 · DWC
3M Health Care, Sarns
Cardiovascular · 72d
Cleared Nov 03, 1988
PREDICTOR II SIGNAL AVERAGING ECG
K883855 · DXG
Corazonix Corp.
Cardiovascular · 51d
Cleared Nov 03, 1988
GUIDING CATHETER (TIP SOFTNESS CHANGE)
K883981 · DWF
Devices For Vascular Intervention, Inc.
Cardiovascular · 43d
Cleared Nov 01, 1988
Q4000 OPTION FOR Q4000
K882978 · DSI
Quinton, Inc.
Cardiovascular · 109d
Cleared Oct 28, 1988
PERMANENT PACING LEADS PYBJ SERIES
K882345 · DTB
Oscor Medical Corp.
Cardiovascular · 143d
Cleared Oct 28, 1988
PERMANENT PACING LEAD MODEL RXBJ SERIES
K882462 · DTB
Oscor Medical Corp.
Cardiovascular · 135d
Cleared Oct 28, 1988
0.014 PERIPHERAL GUIDE WIRE
K882804 · DQX
Intensive Technology, Inc.
Cardiovascular · 113d
Cleared Oct 28, 1988
3D VASCULAR RECORDER
K883908 · JOM
D. E. Hokanson, Inc.
Cardiovascular · 43d
Cleared Oct 28, 1988
ROTATING HEMOSTATIC VALVE
K883916 · DQY
Devices For Vascular Intervention, Inc.
Cardiovascular · 42d
Cleared Oct 28, 1988
BIO-MEDICUS TUBING CONNECTORS
K883956 · DTL
Bio Medicus, Inc.
Cardiovascular · 39d
Cleared Oct 19, 1988
CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS
K873772 · DTB
Cordis Leads, Inc.
Cardiovascular · 399d
Cleared Oct 19, 1988
WILSON BIOMEDICAL CORONARY GUIDING CATHETER
K881793 · DQY
Wilson Biomedical, Inc.
Cardiovascular · 176d
Cleared Oct 17, 1988
CARDIOMEGA-T
K883410 · DSI
Grandcor Medical Systems
Cardiovascular · 67d
Cleared Oct 17, 1988
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
K883436 · DXO
Ppg Industries, Inc.
Cardiovascular · 63d
Cleared Oct 17, 1988
MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER
K884023 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 25d
Cleared Oct 14, 1988
AIR PLETHYSMOGRAPH MODEL APG-1000
K881291 · DSB
Aci Medical, Inc.
Cardiovascular · 200d
Cleared Oct 14, 1988
BLOOD PRESSURE CUFF
K881799 · DXQ
Biomedical Dynamics, Inc.
Cardiovascular · 170d
Cleared Oct 14, 1988
MULTI-MED INFUSION CATHETER AND KIT DOUBLE/TRIPLE
K883174 · DQY
Baxter Healthcare Corp
Cardiovascular · 79d
Cleared Oct 14, 1988
MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD
K883265 · DTB
Telectronics and Cordis Pacing Systems
Cardiovascular · 74d
Cleared Oct 14, 1988
ACS INDEFLATOR P/T 20
K883452 · DXT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 63d
Cleared Oct 14, 1988
POLYSAFE(TM) IMPLANTABLE PACING LEAD
K884024 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 22d
Cleared Oct 13, 1988
MEDTRONIC MODEL 4951P
K881810 · DTB
Medtronic Vascular
Cardiovascular · 168d
Cleared Oct 13, 1988
CENTRIFUGAL PUMP SYSTEM LX/DX VERSION
K882758 · KFM
3M Health Care, Sarns
Cardiovascular · 100d