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
4345–4368 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 24, 2013
RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER
K130911 · LIT
Ev3, Inc.
Cardiovascular · 52d
Cleared May 24, 2013
MOBICATH BI-DIRECTIONAL GUIDING SHEATH
K130559 · DYB
Great Batch Medical
Cardiovascular · 81d
Cleared May 16, 2013
ELITE-I (BI) DUAL LUMEN CATHETER
K130639 · DWF
Maquet Cardiopulmonary, AG
Cardiovascular · 66d
Cleared May 15, 2013
BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT
K130366 · DTK
C.R. Bard, Inc.
Cardiovascular · 91d
Cleared May 15, 2013
WRIST AUTOMATIC BLOOD PRESSURE MONITOR
K123800 · DXN
Little Doctor Electronic...
Cardiovascular · 156d
Cleared May 14, 2013
ITCLAMP 50
K123551 · DXC
Innovative Trauma Care, Inc.
Cardiovascular · 176d
Cleared May 14, 2013
VASCULAR CLAMPS
K123077 · DXC
Hebumedical GmbH
Cardiovascular · 225d
Cleared May 13, 2013
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+...
K122013 · DXN
Microlife Corp.
Cardiovascular · 307d
Cleared May 09, 2013
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
K130796 · MWI
Covidien
Cardiovascular · 48d
Cleared May 08, 2013
MEDLINE BLOOD PRESSURE TRANSDUCER
K123095 · DRS
Medline Industries, Inc.
Cardiovascular · 218d
Cleared May 03, 2013
SLEEK OTW PTA CATHETER
K130786 · LIT
C.R. Bard, Inc.
Cardiovascular · 43d
Cleared May 03, 2013
ENSITE VELOCITY SYSTEM
K130594 · DQK
St Jude Medical
Cardiovascular · 57d
Cleared May 03, 2013
DIGITAL BLOOD PRESSURE MONITOR
K123600 · DXN
Little Doctor Electronic...
Cardiovascular · 163d
Cleared May 03, 2013
SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM
K121404 · DYB
Onset Medical Corporation
Cardiovascular · 358d
Cleared May 02, 2013
DVTCARE CA5
K130174 · JOW
Ossur Americas, Inc.
Cardiovascular · 98d
Cleared May 01, 2013
MAC-LAB HEMODYNAMIC RECORDING SYSTEM
K130626 · DQK
Ge Medical Systems Information...
Cardiovascular · 54d
Cleared Apr 30, 2013
WVSM (WIRLESS VITAL SIGNS MONITOR)
K130957 · MWI
Athena Gtx
Cardiovascular · 25d
Cleared Apr 29, 2013
COMBAT READY CLAMP
K130482 · DXC
Combat Medical Systems, LLC
Cardiovascular · 63d
Cleared Apr 29, 2013
REFLOW ASPIRATION CATHETER
K123482 · QEZ
Volcano Corporation
Cardiovascular · 167d
Cleared Apr 26, 2013
SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING
K123990 · DYB
Medtronic Vascular
Cardiovascular · 121d
Cleared Apr 26, 2013
BODYTRONIC 200
K123921 · JOM
Bauerfeind AG
Cardiovascular · 127d
Cleared Apr 24, 2013
VASCULAR PROBE, VASCULAR PROBE ES
K130896 · DWP
Synovis Life Technologies, Inc.
Cardiovascular · 23d
Cleared Apr 24, 2013
BIOMODULE 3-M1
K123658 · DRX
Zephyr Technology Corporation
Cardiovascular · 147d
Cleared Apr 24, 2013
RHYTHM VIEW
K123295 · DQK
Topera, Inc.
Cardiovascular · 184d