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
2665–2688 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 15, 2017
Raider Guidewire
K173532 · DQX
Vascular Solutions, Inc.
Cardiovascular · 30d
Cleared Dec 15, 2017
PROTEUS PTA Balloon Catheter with Embolic Capture Feature
K172494 · LIT
Angioslide, Ltd.
Cardiovascular · 119d
Cleared Dec 15, 2017
BioFlux Device
K172311 · DXH
Biotricity, Inc.
Cardiovascular · 136d
Cleared Dec 15, 2017
V10
K170497 · DXN
Mediana Co., Ltd.
Cardiovascular · 301d
Cleared Dec 15, 2017
FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
K170029 · KFM
International Biophysics Corporation
Cardiovascular · 345d
Cleared Dec 15, 2017
ECG Acquisition Systems
K163607 · DPS
Vales & Hills Biomedical Tech. , Ltd.
Cardiovascular · 359d
Cleared Dec 13, 2017
Advocate PTA Catheter
K173621 · LIT
Merit Medical Systems, Inc.
Cardiovascular · 21d
Cleared Dec 13, 2017
True Flow Valvuloplasty Perfusion Catheter
K172932 · OZT
C.R. Bard, Inc.
Cardiovascular · 78d
Cleared Dec 12, 2017
Disposable High Pressure Syringe
K170279 · DXT
Union Medical Shenzhen Co., Ltd.
Cardiovascular · 316d
Cleared Dec 08, 2017
CMS-2000 Central Monitoring System
K172966 · MHX
Advanced Instumentations, Inc.
Cardiovascular · 73d
Cleared Dec 07, 2017
Lunderquist Extra Stiff Wire Guide
K171513 · DQX
William Cook Europe Aps
Cardiovascular · 197d
Cleared Dec 06, 2017
091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm
K172468 · DQY
Inneuroco, Inc.
Cardiovascular · 113d
Cleared Dec 04, 2017
ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath
K173470 · QEW
Inari Medical
Cardiovascular · 26d
Cleared Dec 04, 2017
PhotoFix Decellularized Bovine Pericardium
K172085 · PSQ
Cryolife, Inc.
Cardiovascular · 146d
Cleared Dec 01, 2017
Octane aspiration system
K173266 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 51d
Cleared Nov 30, 2017
Endophys Pressure Sensing Sheath Kit- 8F
K173399 · DYB
Endophys Holdings, LLC
Cardiovascular · 30d
Cleared Nov 30, 2017
HeRO Graft
K172637 · DSY
Merit Medical Systems, Inc.
Cardiovascular · 90d
Cleared Nov 27, 2017
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser...
K172687 · MCW
Spectranetics, Inc.
Cardiovascular · 82d
Cleared Nov 27, 2017
Devon 51
K172030 · JOW
Devon Medical Products (Jiangsu), Ltd.
Cardiovascular · 145d
Cleared Nov 22, 2017
The Wrist-Type Fully Automatic Digital Blood Pressure Monitors
K170666 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 261d
Cleared Nov 21, 2017
Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath,...
K172995 · DYB
Terumo Medical Corporation
Cardiovascular · 55d
Cleared Nov 21, 2017
TXM Hydrophilic Guidewire
K170915 · DQX
Texasmedical Technologies, Inc.
Cardiovascular · 238d
Cleared Nov 21, 2017
TXM Support Catheter
K170914 · DQY
Texasmedical Technologies, Inc.
Cardiovascular · 238d
Cleared Nov 21, 2017
Automatic Wrist Bluetooth Blood Pressure Monitor
K170545 · DXN
Truly Instrument , Ltd.
Cardiovascular · 270d