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
13393–13416 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 16, 1988
POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP
K883016 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 59d
Cleared Sep 16, 1988
INTERSEPT*PREBYPASS FILTER
K883086 · KRJ
Medtronic Blood Systems, Inc.
Cardiovascular · 57d
Cleared Sep 14, 1988
OMEGA NV(TM) BALLOON DILATATION CATHETER
K882052 · LIT
Cook, Inc.
Cardiovascular · 121d
Cleared Sep 14, 1988
PROLOG MP 658M PULSE GENERATOR
K883087 · DXY
Pacesetter Systems
Cardiovascular · 55d
Cleared Sep 12, 1988
TRU-TRAC COILED GUIDEWIRE
K880287 · DQX
N-S Medical Products
Cardiovascular · 231d
Cleared Sep 12, 1988
TRU-TRAC TORQUE GUIDEWIRE
K880288 · DQX
N-S Medical Products
Cardiovascular · 231d
Cleared Sep 12, 1988
OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004
K882474 · DXY
Ela Medical, Inc.
Cardiovascular · 89d
Cleared Sep 12, 1988
OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004
K882476 · DXY
Ela Medical, Inc.
Cardiovascular · 89d
Cleared Sep 12, 1988
PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER)
K882879 · DXC
Pioneering Technologies, Inc.
Cardiovascular · 63d
Cleared Sep 12, 1988
MX860, REUSABLE PRESSURE TRANSDUCER
K883095 · DRS
Medex, Inc.
Cardiovascular · 52d
Cleared Sep 12, 1988
HEARTSTART 1000
K883341 · MKJ
Laerdal Mfg. Corp.
Cardiovascular · 34d
Cleared Sep 12, 1988
HEARTSTART 1000S
K883344 · MKJ
Laerdal Mfg. Corp.
Cardiovascular · 34d
Cleared Sep 08, 1988
MYOCARD BIOPSY FORCEP
K881412 · DWZ
Fehling Medizintechnik GmbH
Cardiovascular · 157d
Cleared Sep 06, 1988
NUMED BALLOON THERMODILUTION CATHETER
K881893 · KRB
NuMED, Inc.
Cardiovascular · 124d
Cleared Sep 06, 1988
BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER
K882330 · LDF
C.R. Bard, Inc.
Cardiovascular · 92d
Cleared Sep 06, 1988
RK2000 K-THERMIA SYSTEM
K882442 · DWJ
Baxter Healthcare Corp
Cardiovascular · 84d
Cleared Sep 06, 1988
MODEL 5866-34A PACEMAKER LEAD ADAPTOR
K883203 · DTB
Medtronic Vascular
Cardiovascular · 40d
Cleared Sep 06, 1988
BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD
K883602 · DTB
Intermedics, Inc.
Cardiovascular · 14d
Cleared Sep 02, 1988
L-F COILED EXTENSION TUBING
K882329 · DXT
Mallinckrodt Group, Inc.
Cardiovascular · 88d
Cleared Aug 30, 1988
DIGITAL MEDICINE ECG MONITOR AND RECORDER
K880971 · DXH
Digital Medicine Systems
Cardiovascular · 175d
Cleared Aug 30, 1988
ACS DEFLECTABLE TIP GUIDE WIRE W/MICROGLIDE(R)COAT
K882321 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 85d
Cleared Aug 30, 1988
MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE
K882338 · DRO
Cardiotronics, Inc.
Cardiovascular · 85d
Cleared Aug 30, 1988
DIGITAL BLOOD PRESSURE MONITOR MODEL HEM-703CP
K882393 · DXN
Omron Electronics, Inc.
Cardiovascular · 81d
Cleared Aug 30, 1988
MODEL #918 MULTI-PADS
K883375 · DRO
Cardiotronics, Inc.
Cardiovascular · 21d