FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
12481–12504 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 09, 1990
GREENFIELD VENA CAVA FILTER W/19.5 FR INTRODUCER
K901235 · DTK
Boston Scientific Corp
Cardiovascular · 209d
Cleared Oct 09, 1990
RTM 36-05, 60-05, RTD 36-05, 60-05 RADIO. LEADWIRE
K901780 · DSA
Medtronic Vascular
Cardiovascular · 175d
Cleared Oct 09, 1990
SCIMED ENCORE INFLATION DEVICE, MODEL SM2500
K903503 · MAV
Scimed
Cardiovascular · 67d
Cleared Oct 09, 1990
ADVANCE LASER FLOWMETER, ALF 21
K903633 · DPW
Transonic Systems, Inc.
Cardiovascular · 60d
Cleared Oct 09, 1990
DATASCOPE PERCOR STAT DL10.5 FR40CC IN AORTIC BAL
K903736 · DSP
Datascope Corp.
Cardiovascular · 54d
Cleared Oct 09, 1990
MODEL 9444 TELETRACE II ECG MONITORING SYSTEM
K903960 · DXH
Medtronic Vascular
Cardiovascular · 42d
Cleared Oct 03, 1990
RSI FEMORAL GUIDING CATHETER
K902943 · DQO
Retroperfusion Systems, Inc.
Cardiovascular · 90d
Cleared Oct 02, 1990
THE OPHTHIMUS SYSTEM
K896017 · DQK
Hightech Vision
Cardiovascular · 351d
Cleared Sep 28, 1990
SOFTOUCH GUIDING CATHETER
K902953 · DQO
Mallinckrodt Medical
Cardiovascular · 85d
Cleared Sep 27, 1990
ROADRUNNER WIRE GUIDE
K901899 · DQX
Cook, Inc.
Cardiovascular · 153d
Cleared Sep 27, 1990
RESUBMITTED MULTIORGAN PERFUSION CANNULA
K902394 · DWF
Fresenius USA, Inc.
Cardiovascular · 120d
Cleared Sep 27, 1990
MODIFIED HEARTSTART DEFIBRILLATION ELECTRODE
K902429 · LDD
Laerdal Mfg. Corp.
Cardiovascular · 128d
Cleared Sep 27, 1990
BARD FILTERED CARDIOTOMY RESERVOIR
K902856 · DTP
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Sep 27, 1990
SITERITE NEEDLE GUIDE
K903158 · DQY
Dymax Corp
Cardiovascular · 71d
Cleared Sep 27, 1990
GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER
K903606 · LIT
North American Instrument Corp.
Cardiovascular · 59d
Cleared Sep 26, 1990
MODELS 5069/5071 MYOCARDIAL PACING LEADS
K902002 · DTB
Medtronic Vascular
Cardiovascular · 147d
Cleared Sep 26, 1990
SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER
K902091 · LIT
Schneider Intl., Ltd.
Cardiovascular · 140d
Cleared Sep 26, 1990
PERCUTANEOUS INTRODUCER SET
K902275 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 128d
Cleared Sep 26, 1990
MEDRAD MARK V-PLUS INJECTOR
K903390 · DXT
Medrad, Inc.
Cardiovascular · 61d
Cleared Sep 26, 1990
PERCUTANEOUS CATHETER INTRODUCER KIT
K903906 · DYB
Intec Medical, Inc.
Cardiovascular · 34d
Cleared Sep 25, 1990
PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG
K902057 · DSP
Datascope Corp.
Cardiovascular · 141d
Cleared Sep 19, 1990
TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN
K903414 · DXK
Echo Ultrasound
Cardiovascular · 51d
Cleared Sep 14, 1990
9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON
K892222 · DSP
Kontron Instruments, Inc.
Cardiovascular · 529d
Cleared Sep 14, 1990
CRI CYNOSAR CATHETER
K900320 · DRA
Catheter Research C/O Burditt, Bowles...
Cardiovascular · 234d