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
13993–14016 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 22, 1987
ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER
K871140 · DYB
Aries Medical, Inc.
Cardiovascular · 30d
Cleared Apr 22, 1987
URESIL CAROTID ARTERY SIZERS
K871148 · DRE
Uresil Corp.
Cardiovascular · 30d
Cleared Apr 20, 1987
SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM
K865101 · DXG
Spectramed, Inc.
Cardiovascular · 111d
Cleared Apr 20, 1987
CARDIOTEAM
K870527 · DXH
Cardiac Network, Inc.
Cardiovascular · 70d
Cleared Apr 20, 1987
PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS
K871132 · DYB
Deltec Systems, Inc.
Cardiovascular · 31d
Cleared Apr 13, 1987
ELITE ELECTROCARDIOGRAPH
K870920 · LOS
Burdick Corp.
Cardiovascular · 38d
Cleared Apr 10, 1987
HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER
K861505 · DXG
American Medical Equipment, Inc.
Cardiovascular · 352d
Cleared Apr 10, 1987
FIBRE OPTIC STRIP CHART RECORDER
K870119 · DSF
Apex Imaging Corp.
Cardiovascular · 88d
Cleared Apr 10, 1987
HEART*AID 1000
K870622 · MKJ
Cardiac Resucitator Corp.
Cardiovascular · 57d
Cleared Apr 10, 1987
MD MONITORING/DIAGNOSTIC ELECTRODE
K870873 · DRX
Lectec Corp.
Cardiovascular · 38d
Cleared Apr 10, 1987
MODEL 435-03 SIDE HOOK IMPLANTABLE PACING LEAD
K870948 · DTB
Intermedics, Inc.
Cardiovascular · 32d
Cleared Apr 09, 1987
MEDI-TECH SELECTIVE TORQUE CATHETER
K864118 · DQY
Medi-Tech, Inc.
Cardiovascular · 170d
Cleared Apr 09, 1987
Q5000 STRESS TEST MONITOR
K864504 · DPS
Quinton, Inc.
Cardiovascular · 146d
Cleared Apr 09, 1987
ACKRAD TDI SET
K864818 · KRB
Ackrad Laboratories
Cardiovascular · 121d
Cleared Apr 09, 1987
ADDITIONAL 13.4CM. FRENCH CATHETER INSERTION TRAY
K870675 · DQY
Quinton, Inc.
Cardiovascular · 49d
Cleared Apr 09, 1987
TITANIUM PERCUTANEOUS GREENFIELD VENA CAVE FILTER
K870729 · DTK
Medi-Tech, Inc.
Cardiovascular · 43d
Cleared Apr 09, 1987
EK10 ELECTROCARDIOGRAPH
K870880 · DPS
Burdick Corp.
Cardiovascular · 36d
Cleared Apr 09, 1987
INTRODUCER, PERCUTANEOUS
K870907 · DYB
Med Fusion Systems, Inc.
Cardiovascular · 35d
Cleared Apr 03, 1987
DEVICE CONNECTORS #000299-000 3/8 X 3/8 X 3/8 Y
K870477
Clinical Connections, Inc.
Cardiovascular · 59d
Cleared Mar 27, 1987
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701
K870728 · DRQ
A&D Engineering, Inc.
Cardiovascular · 31d
Cleared Mar 25, 1987
GUIDE WIRE
K870664 · DQX
Datascope Corp.
Cardiovascular · 34d
Cleared Mar 24, 1987
FUKUDA DENSHI MODEL FCP-15
K871025 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 8d
Cleared Mar 23, 1987
MODIFIED DRAGER SPHYGMOMED
K862427 · DXN
Draeger Medical, Inc.
Cardiovascular · 270d
Cleared Mar 23, 1987
HEART TRACK
K864293 · DXH
Cardio Telemetric Systems, Inc.
Cardiovascular · 143d