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
4633–4656 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 17, 2012
MEDLINE HIGH PRESSURE INJECTION TUBING
K120008 · DQO
Medline Industries, Inc.
Cardiovascular · 227d
Cleared Aug 16, 2012
CHORD-X EPTFE SUTURE
K121173 · PAW
On-Xlifetechnologies
Cardiovascular · 121d
Cleared Aug 15, 2012
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE...
K122070 · LIT
Trireme Medical, Inc.
Cardiovascular · 30d
Cleared Aug 15, 2012
VISI MOBILE MONITORING SYSTEM
K122036 · MWI
Sotera Wireless, Inc.
Cardiovascular · 35d
Cleared Aug 15, 2012
ARMADA 14XXT PTA CATHETER
K121352 · DQY
Abbott Vascular
Cardiovascular · 103d
Cleared Aug 14, 2012
TABLET COMMANDER
K122285 · DRG
Cardiocom, LLC
Cardiovascular · 15d
Cleared Aug 14, 2012
AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE
K121776 · DQX
Codman & Shurtleff, Inc.
Cardiovascular · 57d
Cleared Aug 14, 2012
CONNECTED CARE CLINICAL APPLICATION
K120320 · DXN
Watermark Medical, Inc.
Cardiovascular · 194d
Cleared Aug 14, 2012
CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS
K120158 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 209d
Cleared Aug 14, 2012
BIOHARNESS
K113045 · MHX
Zephyr Technology Corporation
Cardiovascular · 306d
Cleared Aug 13, 2012
NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)
K121667 · LOX
Boston Scientific Corp
Cardiovascular · 68d
Cleared Aug 10, 2012
SCEPTER C OCCLUSION BALLOON CATHETER
K121785 · MJN
MicroVention, Inc.
Cardiovascular · 53d
Cleared Aug 10, 2012
AIMAGO EASYLDI MICROCIRCULATION CAMERA
K121429 · DPT
Aimago SA
Cardiovascular · 88d
Cleared Aug 10, 2012
BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
K121197 · DSI
Preventice, Inc.
Cardiovascular · 113d
Cleared Aug 10, 2012
ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY...
K120554 · DXN
Sejoy Electronics & Instruments Co.,...
Cardiovascular · 169d
Cleared Aug 09, 2012
CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH
K120781 · DQY
Fuji Systems Corp.
Cardiovascular · 147d
Cleared Aug 08, 2012
UNBALLOON NON-OCCLUSIVE MODELING CATHETER
K121839 · DQY
LeMaitre Vascular, Inc.
Cardiovascular · 47d
Cleared Aug 08, 2012
APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH
K121168 · OTD
Aptus Endosystems, Inc.
Cardiovascular · 113d
Cleared Aug 08, 2012
CONVEY GUIDING CATHETER
K120585 · DQY
Pendracare International, B.V.
Cardiovascular · 163d
Cleared Aug 08, 2012
KENT CAMERA
K113507 · MUD
Kent Imaging, Inc.
Cardiovascular · 254d
Cleared Aug 06, 2012
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K121158 · NLH
Sterilmed, Inc.
Cardiovascular · 112d
Cleared Aug 06, 2012
HEART SYNC PEDIATRIC PHYSIO AED PAD
K120536 · MKJ
Heart Sync, Inc.
Cardiovascular · 166d
Cleared Aug 02, 2012
PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE
K122121 · DXG
Pulsion Medical Systems SE
Cardiovascular · 16d
Cleared Aug 02, 2012
ELI 280 ELECTROCARDIOGRAPH
K122073 · DPS
Mortara Instrument, Inc.
Cardiovascular · 17d