FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,151 results
11545–11568 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 16, 1993
DISPOSABLE STEERABLE ANGIOSCOPE
K931421 · LYK
Endovascular, Inc.
Cardiovascular · 86d
Cleared Jun 10, 1993
MODEL 1148T TRANSVENOUS, SCREW-IN LEAD
K925347 · DTB
Siemens-Pacesetter, Inc.
Cardiovascular · 231d
Cleared Jun 10, 1993
TERUMO CORONARY GUIDE WIRE
K925852 · DQX
Terumo Medical Corp.
Cardiovascular · 205d
Cleared Jun 07, 1993
PLEXUS PULSER I, PLEXUS PULSER II
K924891 · JOW
Dobre, Inc.
Cardiovascular · 252d
Cleared Jun 07, 1993
SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR
K925075 · DTZ
3M Health Care, Sarns
Cardiovascular · 243d
Cleared Jun 07, 1993
SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R.
K925076 · DTZ
3M Health Care, Sarns
Cardiovascular · 243d
Cleared Jun 07, 1993
SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER
K926003 · DQO
Schneider Intl., Ltd.
Cardiovascular · 192d
Cleared Jun 07, 1993
SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIO
K926271 · LIT
Schneider Intl., Ltd.
Cardiovascular · 171d
Cleared Jun 04, 1993
CARDIO2 CYCLE
K926233 · KRI
Ergometrix, Inc.
Cardiovascular · 175d
Cleared Jun 04, 1993
DOC-TITE(TM) GUIDE WIRE EXTENSION
K931171 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 88d
Cleared Jun 02, 1993
MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150
K926357 · DWA
Medtronic Bio-Medicus, Inc.
Cardiovascular · 163d
Cleared May 27, 1993
ATRIUM'S HYBRID PTFE
K925123 · DSY
Atrium Medical Corp.
Cardiovascular · 226d
Cleared May 27, 1993
DUAL LUMEN L-CATH CATHETER SYSTEM
K925979 · DQX
Luther Medical Products, Inc.
Cardiovascular · 183d
Cleared May 27, 1993
NEW LEAD INTRODUCER KITS, VARIOUS MODELS
K926340 · DYB
Telectronics Pacing Systems, Inc.
Cardiovascular · 161d
Cleared May 27, 1993
CLEANCUFF(TM)
K931087 · DXQ
Med-Con, Inc.
Cardiovascular · 85d
Cleared May 27, 1993
CORDIS NIHON CATHETER SHEATH INTRODUCER
K931102 · DYB
Cordis Corp.
Cardiovascular · 85d
Cleared May 27, 1993
HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC
K931386 · DXZ
Meadox Medicals, Div. Boston...
Cardiovascular · 70d
Cleared May 26, 1993
BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE
K921388 · DSK
Biochem International, Inc.
Cardiovascular · 429d
Cleared May 26, 1993
CRI ELECTRONIC CONTROL SYSTEM
K924125 · DXX
Catheter Research C/O Burditt, Bowles...
Cardiovascular · 282d
Cleared May 26, 1993
URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS
K930011 · MGZ
Uresil Corp.
Cardiovascular · 142d
Cleared May 26, 1993
CATHETER GUIDEWIRE (PERIPHERAL USE)
K930961 · DQX
Target Therapeutics
Cardiovascular · 91d
Cleared May 24, 1993
SELECTIVE INFUSION II CATHETER
K914751 · KRA
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 580d
Cleared May 21, 1993
SARNS RETROGRADE CANNULA
K925442 · DWF
3M Health Care, Sarns
Cardiovascular · 205d
Cleared May 21, 1993
AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01
K925899 · DSK
Welch Allyn, Inc.
Cardiovascular · 182d