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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,151 results
13609–13632 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 09, 1988
RIGHT ATRIAL CATHETER INSERTION TRAY
K881352 · DWF
Quinton, Inc.
Cardiovascular · 71d
Cleared Jun 02, 1988
WORKSTATION PLUS W/LOCAL AREA NETWORK(LAN) OPTION
K880879 · DQK
Ppg Industries, Inc.
Cardiovascular · 93d
Cleared Jun 01, 1988
APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300
K873214 · DPT
General Electric Co.
Cardiovascular · 292d
Cleared Jun 01, 1988
ACCUCOM 2
K874138 · DPT
Datascope Corp.
Cardiovascular · 232d
Cleared May 31, 1988
IMPLANTABLE ELECTRODE LEAD, MODEL 030-446
K874664 · DTB
Telectronics, Inc.
Cardiovascular · 200d
Cleared May 31, 1988
ACS FUNNEL INTRODUCER
K875158 · DYB
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 168d
Cleared May 31, 1988
HORIZON 9000
K875167 · DXG
Mennen Medical, Inc.
Cardiovascular · 167d
Cleared May 31, 1988
CONTRAST INJECTION DEVICE
K880877 · DXT
Med-West, Inc.
Cardiovascular · 91d
Cleared May 31, 1988
SHILEY FEMORAL ARTERIAL CANNULA
K881072 · DWF
Shiley, Inc.
Cardiovascular · 78d
Cleared May 31, 1988
SHILEY FEMORAL VENOUS CANNULA
K881074 · DWF
Shiley, Inc.
Cardiovascular · 78d
Cleared May 31, 1988
ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM)
K881088 · LIT
Devices For Vascular Intervention, Inc.
Cardiovascular · 77d
Cleared May 31, 1988
CARDICAD(TM)
K881392 · DWS
Medical/Surgical Specialties, Ltd.
Cardiovascular · 57d
Cleared May 31, 1988
MODIFIED SERVO SYRINGE
K881521 · DXT
Engineering, Inc.
Cardiovascular · 53d
Cleared May 31, 1988
EPICARDIA LE/FD
K881770 · DQK
Medicomp, Inc.
Cardiovascular · 35d
Cleared May 26, 1988
CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015
K880860 · DQT
Dlp, Inc.
Cardiovascular · 86d
Cleared May 26, 1988
MEADOX INTRA-AORTIC GRAFT
K881283 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 62d
Cleared May 26, 1988
VICOR MODELS 410B & 410D AND MODIFIED 410A PACEMA.
K881711 · DXY
Telectronics and Cordis Pacing Systems
Cardiovascular · 36d
Cleared May 25, 1988
SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD
K874465 · DYG
Abbott Laboratories
Cardiovascular · 208d
Cleared May 25, 1988
MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
K875178 · DTB
Intermedics, Inc.
Cardiovascular · 160d
Cleared May 25, 1988
HEPARIN COATED LUMINAL PACING CATHETER
K875337 · DQO
Spectramed, Inc.
Cardiovascular · 147d
Cleared May 25, 1988
MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER
K880231 · DQT
Ideas For Medicine, Inc.
Cardiovascular · 133d
Cleared May 25, 1988
OCHSNER & MICRON FABRIC PATCH
K881508 · DXZ
Intervascular, Inc.
Cardiovascular · 44d
Cleared May 25, 1988
MEDTRONIC MODEL 5866-36 LEAD ADAPTOR KIT
K881712 · DTB
Medtronic Vascular
Cardiovascular · 34d
Cleared May 24, 1988
MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
K875100 · DTB
Intermedics, Inc.
Cardiovascular · 166d