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
2521–2544 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 25, 2018
Quantum Pump Console
K173834 · DTQ
Spectrum Medical , Ltd.
Cardiovascular · 158d
Cleared May 25, 2018
STAR 65
K172147 · MWI
Skanray Technologies Pvt, Ltd.
Cardiovascular · 312d
Cleared May 23, 2018
Route 92 Medical Access System
K180201 · DQY
Route 92 Medical, Inc.
Cardiovascular · 119d
Cleared May 22, 2018
Pantheris System
K173862 · MCW
Avinger, Inc.
Cardiovascular · 153d
Cleared May 18, 2018
The IQoolTM Warm System
K180375 · DWJ
Braincool AB
Cardiovascular · 95d
Cleared May 17, 2018
Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
K181042 · DXK
Boston Scientific Corporation
Cardiovascular · 28d
Cleared May 17, 2018
Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon...
K181023 · LOX
Meril Life Sciences Private Limited
Cardiovascular · 30d
Cleared May 17, 2018
EnsoETM
K180742 · PLA
Advanced Cooling Therapy, Inc. D/B/A...
Cardiovascular · 56d
Cleared May 17, 2018
FlowTriever Retrieval/Aspiration System
K180466 · QEW
Inari Medical, Inc.
Cardiovascular · 85d
Cleared May 15, 2018
XableCath Support Catheter Product Family
K180986 · DQY
Xablecath, Inc.
Cardiovascular · 29d
Cleared May 15, 2018
Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and...
K180412 · QEW
Penumbra, Inc.
Cardiovascular · 89d
Cleared May 11, 2018
µCor Heart Failure and Arrhythmia Management System
K172510 · MHX
Zoll Manufacturing Corporation
Cardiovascular · 263d
Cleared May 10, 2018
FORE-SIGHT ELITE Module Tissue Oximeter
K180003 · MUD
Cas Medical Systems, Inc.
Cardiovascular · 128d
Cleared May 10, 2018
ANGIO-PRESS LITE DVT Compression Device
K173012 · JOW
Pegasus Medical Supply, Inc.
Cardiovascular · 225d
Cleared May 09, 2018
VSI Micro-Introducer Kit
K180913 · DYB
Vascular Solutions, Inc.
Cardiovascular · 30d
Cleared May 08, 2018
Glidesheath Slender
K173831 · DYB
Terumo Medical Corporation
Cardiovascular · 141d
Cleared May 08, 2018
BioStamp nPoint
K173510 · DRG
Mc10, Inc.
Cardiovascular · 176d
Cleared May 04, 2018
QT ECG
K180157 · DXH
QT Medical, Inc.
Cardiovascular · 105d
Cleared May 03, 2018
Medtronic Confida Brecker Guidewire
K181001 · DQX
Medtronic Core Valve, LLC
Cardiovascular · 17d
Cleared May 03, 2018
Indigo Aspiration System - Modified 110 Aspiration Tubing
K180939 · QEW
Penumbra, Inc.
Cardiovascular · 23d
Cleared May 03, 2018
Micropuncture Pedal Access Set
K172980 · DYB
Cook Incorporated
Cardiovascular · 218d
Cleared May 01, 2018
PeraServer and PeraTrend
K172959 · MWI
Perahealth, Inc.
Cardiovascular · 217d
Cleared Apr 27, 2018
Novasight Hybrid System
K172258 · OBJ
Conavi Medical, Inc.
Cardiovascular · 275d
Cleared Apr 23, 2018
EnSite Velocity Cardiac Mapping System v5.2
K172396 · DQK
St Jude Medical
Cardiovascular · 258d