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
3889–3912 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 21, 2014
THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE...
K134031 · LOX
Boston Scientific Corporation
Cardiovascular · 202d
Cleared Jul 18, 2014
NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER
K141118 · LIT
Ev3, Inc.
Cardiovascular · 79d
Cleared Jul 16, 2014
STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER
K141112 · LIT
Boston Scientific
Cardiovascular · 77d
Cleared Jul 15, 2014
PULSTAR LOGIX PUMP
K141609 · JOW
Albahealth, LLC
Cardiovascular · 29d
Cleared Jul 15, 2014
REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES
K140813 · JOW
Covidien
Cardiovascular · 105d
Cleared Jul 15, 2014
CORMATRIX ECM FOR VASCULAR REPAIR
K140789 · DXZ
Cormatrix Cardiovascular, Inc.
Cardiovascular · 106d
Cleared Jul 11, 2014
CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION
K141582 · DPS
Welch Allyn
Cardiovascular · 28d
Cleared Jul 09, 2014
INTRODUCER, MODEL ADELANTE MAGNUM
K140917 · DYB
Oscor, Inc.
Cardiovascular · 90d
Cleared Jul 09, 2014
MERIT SAFETY INTRODUCER NEEDLE
K140513 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 131d
Cleared Jul 08, 2014
ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS
K141618 · OBJ
Arrow International, Inc (Subsidiary...
Cardiovascular · 21d
Cleared Jul 07, 2014
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL...
K141432 · DTN
Maquet Cardiopulmonary, AG
Cardiovascular · 38d
Cleared Jul 03, 2014
VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA
K140641 · DYB
Boston Scientific Corporation
Cardiovascular · 113d
Cleared Jul 03, 2014
EDWARDS TRANSFEMORAL BALLOON CATHETER
K140241 · OZT
Edwards Lifesciences, LLC
Cardiovascular · 154d
Cleared Jul 03, 2014
MICROPUNCTURE INTRODUCER SET
K133114 · DYB
Cook Incorporated
Cardiovascular · 276d
Cleared Jul 02, 2014
SPHYGMOMANOMETER
K141392 · DXQ
Suzhou JJ Meter Co., Ltd.
Cardiovascular · 36d
Cleared Jul 02, 2014
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K140572 · DXN
Microlife Intellectual Property GmbH,...
Cardiovascular · 118d
Cleared Jul 02, 2014
ARROW GPSCATH BALLOON DILATATION CATHETER
K140351 · LIT
Hotspur Technologies,Inc Subsidiary...
Cardiovascular · 141d
Cleared Jul 02, 2014
PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY...
K140129 · DQE
Icu Medical, Inc.
Cardiovascular · 167d
Cleared Jul 02, 2014
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K140121 · DXN
Andon Health Co, Ltd.
Cardiovascular · 167d
Cleared Jul 02, 2014
FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM...
K133861 · LIT
Ostial Corporation
Cardiovascular · 195d
Cleared Jul 01, 2014
ODISSEY TISSUE OXIMETER
K141234 · MUD
Vioptix, Inc.
Cardiovascular · 49d
Cleared Jul 01, 2014
EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL...
K141148 · DRE
Cook Vascular, Inc.
Cardiovascular · 57d
Cleared Jul 01, 2014
CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2
K133916 · DQK
Biosense Webster, Inc.
Cardiovascular · 190d
Cleared Jul 01, 2014
HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM,...
K132036 · MSX
Shenzhen Mindray Bio-Meidcal...
Cardiovascular · 365d