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
13777–13800 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 03, 1987
DEKNATEL TEMPORARY CARDIAC PACING WIRE
K873728 · LDF
Deknatel, Inc.
Cardiovascular · 48d
Cleared Oct 30, 1987
THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT
K872090 · DQT
Ideas For Medicine, Inc.
Cardiovascular · 151d
Cleared Oct 30, 1987
IMPRA DUAL LUMEN SUBCLAVIAN CATHETER
K872163 · DQY
Impra, Inc.
Cardiovascular · 147d
Cleared Oct 30, 1987
POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE
K872182 · DQY
Polystan C/O Vitalcor, Inc.
Cardiovascular · 144d
Cleared Oct 26, 1987
MODIFIED Q4000 & Q3040 ELECTROCARDIOGRAPH MONITOR
K873584 · DPS
Quinton, Inc.
Cardiovascular · 52d
Cleared Oct 22, 1987
MODIFIED MODELS 1025M & 1026T PACING LEAD
K873931 · DTB
Pacesetter Systems
Cardiovascular · 38d
Cleared Oct 20, 1987
RT5000 ECHOCARDIOGRAPHY #H4100C/CE
K870726 · JOP
General Electric Co.
Cardiovascular · 238d
Cleared Oct 20, 1987
PATHFINDER 3, AUTO SURVEYOR AND SURVEYOR
K871344 · DSI
Reynolds Medical , Ltd.
Cardiovascular · 197d
Cleared Oct 20, 1987
ACS INDEFLATOR PLUS (MODIFICATION #2)
K872981 · DXT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 81d
Cleared Oct 16, 1987
NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR)
K872871 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 87d
Cleared Oct 15, 1987
DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH.
K872770 · DYG
Nova Medical Specialties
Cardiovascular · 93d
Cleared Oct 15, 1987
VICOR, MODEL 410A
K873202 · DXY
Tpl-Cordis, Inc.
Cardiovascular · 63d
Cleared Oct 09, 1987
BARD EPICARDIAL ELECTRODE ARRAY
K872231 · DRF
C.R. Bard, Inc.
Cardiovascular · 122d
Cleared Oct 09, 1987
MACTRODE-II
K872784 · DRX
Marquette Electronics, Inc.
Cardiovascular · 87d
Cleared Oct 09, 1987
DP-700 NIKMAN DEFIB-PADS
K872793 · LDD
Nikomed U.S.A., Inc.
Cardiovascular · 87d
Cleared Oct 09, 1987
MODEL SSR1 HOLTER MONITOR
K873337 · DSH
Cardiodata Corp.
Cardiovascular · 51d
Cleared Oct 09, 1987
BSK-1033 TELEMETRY MONITORING CABLE
K873492 · DSA
Desco Industries, Inc.
Cardiovascular · 39d
Cleared Oct 09, 1987
MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS
K873528 · DXY
Intermedics, Inc.
Cardiovascular · 38d
Cleared Oct 09, 1987
ANGIOMAT CT INJECTOR
K873687 · DXT
Mallinckrodt Group, Inc.
Cardiovascular · 25d
Cleared Oct 09, 1987
FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER
K873765 · DSK
Nam Tai , Ltd.
Cardiovascular · 23d
Cleared Oct 07, 1987
MODEL 2240 SLAVE SCOPE
K873346 · DPS
Marquette Electronics, Inc.
Cardiovascular · 49d
Cleared Oct 07, 1987
SUTURELESS TEMPORARY EPICARDIAL PACING LEAD
K873474 · LDF
Symbion, Inc.
Cardiovascular · 37d
Cleared Oct 07, 1987
SILENT GUARD CAT. NO. SG-10
K873488 · DTL
American Omni Medical, Inc.
Cardiovascular · 37d
Cleared Oct 07, 1987
PULL-APART INTRODUCER (SHEATH)
K873727 · DYB
Quinton, Inc.
Cardiovascular · 28d