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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
3433–3456 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 14, 2015
Pantheris System
K152275 · MCW
Avinger, Inc.
Cardiovascular · 63d
Cleared Oct 14, 2015
AngioDynamics Mariner Angiographic Catheters
K151724 · DQO
AngioDynamics, Inc.
Cardiovascular · 110d
Cleared Oct 09, 2015
Dyevert Contrast Modulation System
K151746 · DXT
Osprey Medical, Inc.
Cardiovascular · 102d
Cleared Oct 08, 2015
MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM
K152550 · DSI
Medicalgorithmics S.A.
Cardiovascular · 30d
Cleared Oct 08, 2015
Passeo-14 Peripheral Dilatation Catheter
K152240 · LIT
Biotronik, Inc.
Cardiovascular · 59d
Cleared Oct 08, 2015
Passeo-18 Peripheral Dilation Catheter
K151744 · LIT
Biotronik, Inc.
Cardiovascular · 101d
Cleared Oct 06, 2015
iLab Polaris Multi-Modality Guidance System
K151613 · DQK
Boston Scientific Corporation
Cardiovascular · 113d
Cleared Oct 06, 2015
Comet Pressure Guidewire
K151610 · DXO
Boston Scientific Corporation
Cardiovascular · 113d
Cleared Oct 02, 2015
zensor system
K151027 · MHX
Intelesens Limited
Cardiovascular · 168d
Cleared Oct 02, 2015
CorPath 200 System
K150892 · DXX
Corindus, Inc.
Cardiovascular · 183d
Cleared Oct 01, 2015
SonoStik IV Guide Wire Introducer
K152177 · DYB
Sonostik, LLC
Cardiovascular · 58d
Cleared Sep 29, 2015
Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series
K152483 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 29d
Cleared Sep 29, 2015
SureSigns VS3, SureSigns VS4
K151761 · DSJ
Phillips Medical Systems
Cardiovascular · 92d
Cleared Sep 25, 2015
AZUR CX Detachable 35 Coils
K151358 · KRD
MicroVention, Inc.
Cardiovascular · 128d
Cleared Sep 25, 2015
Endoluminal Occlusion System-EOS
K150402 · KRD
Artventive Medical Group, Inc.
Cardiovascular · 219d
Cleared Sep 24, 2015
Metacross OTW PTA Balloon Dilatation Catheter
K152080 · LIT
KANEKA Corporation
Cardiovascular · 59d
Cleared Sep 24, 2015
iHealth BP3L Wireless Blood Pressure Monitor
K152003 · DXN
Andon Health Co, Ltd.
Cardiovascular · 66d
Cleared Sep 23, 2015
Infinity Delta, Infinity Delta XL, Infinity Kappa
K152407 · MHX
Draeger Medical Sytems, Inc.
Cardiovascular · 29d
Cleared Sep 23, 2015
iHealth View BP7S Wireless Blood Pressure Wrist Monitor
K152379 · DXN
Andon Health Co, Ltd.
Cardiovascular · 33d
Cleared Sep 22, 2015
Destino Reach
K151951 · DYB
Oscor, Inc.
Cardiovascular · 69d
Cleared Sep 21, 2015
Hi-Torque Command 18 Guide Wire
K152404 · DQX
Abbott Vascular
Cardiovascular · 27d
Cleared Sep 21, 2015
AVERT Contrast Modulation System
K152218 · DXT
Osprey Medical
Cardiovascular · 45d
Cleared Sep 21, 2015
Chameleon PTA Balloon Catheter
K151678 · LIT
Av Medical Technologies, Ltd.
Cardiovascular · 91d
Cleared Sep 21, 2015
ZelanteDVT Thrombectomy Set
K151313 · QEW
Boston Scientific Corporation
Cardiovascular · 126d