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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,027 results
10849–10872 of 18,027
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 06, 1995
ARBO H85V/H87V/H27V DISPOS MONIT ELECTRODES
K935437 · DRX
Arbo Medical, Inc.
Cardiovascular · 512d
Cleared Apr 06, 1995
BSC/CA MODEL 940 IAB
K940298 · DSP
Boston Scientific Corp
Cardiovascular · 440d
Cleared Apr 06, 1995
QUEST CORONARY SINUS PERFUSION CANNULA -FRCC
K941916 · DWF
Quest Medical, Inc.
Cardiovascular · 352d
Cleared Apr 06, 1995
IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069
K950140 · DTD
Pacesetter, Inc.
Cardiovascular · 83d
Cleared Apr 05, 1995
MEDTRONIC(R) 8.2 FRENCH SHERPA(R) SUPER PEAK FLOW(TM) CORONARY GUIDING CATHETER
K950026 · DQY
Medtronics Interventional Vascular
Cardiovascular · 91d
Cleared Apr 05, 1995
SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER
K950047 · DQY
Isomedix Operations, Inc.
Cardiovascular · 90d
Cleared Apr 05, 1995
ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE
K950156 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 78d
Cleared Apr 05, 1995
SCIMED 6 FRENCH EXPO ANGIOGRAPHIC CATHETER
K950731 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 48d
Cleared Apr 05, 1995
NOVATRANS II
K951129 · DRS
Medex, Inc.
Cardiovascular · 23d
Cleared Apr 04, 1995
CARRYALL ENHANCEMENTS
K943931 · DXH
Instromedix, Inc.
Cardiovascular · 235d
Cleared Mar 31, 1995
BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT
K944844 · DYF
Baxter Healthcare Corp
Cardiovascular · 182d
Cleared Mar 31, 1995
SCIMED(R) SCEPTOR(TM) PTCA GUIDE WIRE
K946240 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 99d
Cleared Mar 31, 1995
M-PATH NITINOL GUIDEWIRE
K946356 · DQX
Microvena Corp.
Cardiovascular · 91d
Cleared Mar 31, 1995
SCIMED(R) CHICE(TM) EXCHANGE PTCA GUIDE WIRE
K950113 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 79d
Cleared Mar 31, 1995
SCIMED(R) CHOICE(TM) PTCA GUIDE WIRE
K950141 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 77d
Cleared Mar 29, 1995
CORDIS AVANTI CATHETER SHEATH INTRODUCER
K945616 · DYB
Cordis Corp.
Cardiovascular · 134d
Cleared Mar 29, 1995
JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE...
K945720 · DWC
Jostra Bentley
Cardiovascular · 128d
Cleared Mar 24, 1995
PRESSSION S III
K942796 · JOW
Chattanooga Group, Inc.
Cardiovascular · 283d
Cleared Mar 23, 1995
9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER
K943919 · DSP
Boston Scientific Corp
Cardiovascular · 223d
Cleared Mar 21, 1995
SIEMENS 1481 T TRANSMITTER, ENHANCED
K945037 · DRG
Siemens Medical Solutions USA, Inc.
Cardiovascular · 159d
Cleared Mar 17, 1995
LOW PRESSURE INJECTION TUBING, COILED LINE, EXTENSION TUBING
K942381 · DXT
Apogee, Inc.
Cardiovascular · 302d
Cleared Mar 17, 1995
SCIMED(R) ENTRE PTCA GUIDE WIRE
K946180 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 87d
Cleared Mar 16, 1995
CARDIOVIT AT-1, P-80
K946205 · DPS
Schiller America, Inc.
Cardiovascular · 85d
Cleared Mar 15, 1995
INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04
K933278 · KRG
Intermedics, Inc.
Cardiovascular · 624d