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
9937–9960 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 19, 1997
BLUE MAX - 20 BALLOON DILATATION CATHETER
K972357 · LIT
Boston Scientific Corp
Cardiovascular · 147d
Cleared Nov 19, 1997
LMI IRRIGATION CATHETER (IGR)
K972623 · DXE
Lucas Medical, Inc.
Cardiovascular · 128d
Cleared Nov 19, 1997
RENEGADE FIBER BRAIDED MICROCATHETER
K973645 · KRA
Boston Scientific Corp
Cardiovascular · 56d
Cleared Nov 18, 1997
SAFPACE SYSTEM
K955829 · LDF
B.Braun Medical, Inc.
Cardiovascular · 693d
Cleared Nov 18, 1997
TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)
K973401 · DQO
Cordis Corp.
Cardiovascular · 70d
Cleared Nov 17, 1997
HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES...
K970938 · DQX
Biocompatibles Cardiovascular, Inc.
Cardiovascular · 249d
Cleared Nov 14, 1997
IBC CARDIAC SUCTION WARD
K963756 · DTS
International Biophysics Corp.
Cardiovascular · 423d
Cleared Nov 13, 1997
IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM
K971868 · MSX
Marquette Electronics, Inc.
Cardiovascular · 177d
Cleared Nov 12, 1997
BCI MODEL 6004 NIBP MONITOR (6004)
K970801 · DXN
Bci Intl., Inc.
Cardiovascular · 253d
Cleared Nov 12, 1997
HEART ACCESS PLUS CARDIAC EVENT RECORDER
K973141 · DXH
Paceart, Inc.
Cardiovascular · 83d
Cleared Nov 07, 1997
ACUITY CENTRAL STATION
K972121 · MLD
Protocol Systems, Inc.
Cardiovascular · 155d
Cleared Nov 06, 1997
LIFEPAK 300
K962359 · MKJ
Physio-Control Corp.
Cardiovascular · 505d
Cleared Nov 06, 1997
(VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY...
K962473 · MSX
Data Critical Corporation
Cardiovascular · 499d
Cleared Nov 06, 1997
QUEST VESSEL CATHETER
K971928 · DWF
Quest Medical, Inc.
Cardiovascular · 163d
Cleared Nov 06, 1997
3M CDI BLOOD PARAMETER MONITORING SYSTEM 500
K972962 · DRY
3M Company
Cardiovascular · 87d
Cleared Nov 06, 1997
DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER
K973007 · DYB
Datascope Corp.
Cardiovascular · 85d
Cleared Nov 04, 1997
TRINITY DVT SYSTEM
K963957 · JOW
Delphi Consulting Group
Cardiovascular · 398d
Cleared Nov 04, 1997
PATHFINDER 3MM MAPPING MICROCATHETER (01-082001)
K970853 · DRF
Cardima, Inc.
Cardiovascular · 242d
Cleared Nov 04, 1997
TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER
K972518 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 120d
Cleared Nov 03, 1997
THEROX INFUSION GUIDEWIRES
K971719 · DQX
Therox, Inc.
Cardiovascular · 178d
Cleared Nov 03, 1997
MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE...
K972944 · DQX
Medtronics Interventional Vascular
Cardiovascular · 84d
Cleared Oct 31, 1997
GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS
K963368 · DXZ
Glycar, Inc.
Cardiovascular · 430d
Cleared Oct 31, 1997
GLYCAR PERICARDIAL PATCH
K963967 · DXZ
Glycar, Inc.
Cardiovascular · 394d
Cleared Oct 31, 1997
RETRIEVER II
K964210 · DQO
Target Therapeutics
Cardiovascular · 374d