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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,027 results
11233–11256 of 18,027
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 07, 1994
MEADOX SURGIMED OLBERT CATHETER SYSTEM NOPROFILE
K934411 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 119d
Cleared Jan 06, 1994
CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF
K933235 · DWZ
Cordis Corp.
Cardiovascular · 232d
Cleared Jan 05, 1994
SCIMED MAVERICK
K934793 · LIT
Scimed Peripheral Interventions
Cardiovascular · 91d
Cleared Dec 29, 1993
NAMTAI
K935652 · DXN
Nam Tai Electronics (Canada) , Ltd.
Cardiovascular · 36d
Cleared Dec 27, 1993
PATIENT CABLE
K932704 · DSA
Sentry Medical Products, Inc.
Cardiovascular · 207d
Cleared Dec 27, 1993
AVOXIMETER
K932954 · DQK
A-Vox Systems, Inc.
Cardiovascular · 193d
Cleared Dec 27, 1993
CORDIS OPTA 5(TM), MODIFICATION
K933236 · LIT
Cordis Corp.
Cardiovascular · 207d
Cleared Dec 21, 1993
TYSHAK PERIPHERAL BALLOON DILATION CATHETER
K931009 · LIT
NuMED, Inc.
Cardiovascular · 305d
Cleared Dec 21, 1993
CARDIMA TRACKER(R) INFUSION CATHETER
K932800 · KRA
Cardima, Inc.
Cardiovascular · 195d
Cleared Dec 16, 1993
TRACFINDER II
K924108 · DRF
Ep Technologies, Inc.
Cardiovascular · 489d
Cleared Dec 16, 1993
STEEROCATH II
K924109 · DRF
Ep Technologies, Inc.
Cardiovascular · 489d
Cleared Dec 16, 1993
516YT DISPLAY DRIVER
K926219 · DXJ
Vidco, Inc.
Cardiovascular · 371d
Cleared Dec 16, 1993
XDCS-100
K932083 · DXT
Microwave Medical Systems, Inc.
Cardiovascular · 230d
Cleared Dec 16, 1993
ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT...
K934602 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 83d
Cleared Dec 16, 1993
LIFEPAK 9 DEFIBRILLATOR/MONITOR
K935674 · LDD
Physio-Control Corp.
Cardiovascular · 8d
Cleared Dec 15, 1993
MODIFICATIONS TO INTRA-AORTIC BALLOONS
K932268 · DSP
Kontron Instruments, Inc.
Cardiovascular · 259d
Cleared Dec 15, 1993
SCIMED(R) DISPATCH(TM) CORONARY INFUSION CATHETER
K932616 · KRA
Scimed Life Systems, Inc.
Cardiovascular · 197d
Cleared Dec 10, 1993
VALVE SIZER
K934951 · DTI
Carbomedics, Inc.
Cardiovascular · 53d
Cleared Dec 09, 1993
NEW BLUE MAX BALLOON DILATATION CATHETER
K934191 · LIT
Boston Scientific Corp
Cardiovascular · 105d
Cleared Dec 09, 1993
LOC GUIDE WIRE EXTENSION
K934339 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 93d
Cleared Dec 09, 1993
VANTAGE DIALTAION CATHETER
K934433 · LIT
Peripheral Systems Group
Cardiovascular · 87d
Cleared Dec 08, 1993
MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS
K932172 · DTB
Medtronic Vascular
Cardiovascular · 217d
Cleared Dec 08, 1993
SCIMED MAVERICK PTA CATHETER
K932537 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 196d
Cleared Dec 08, 1993
FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS
K933943 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 114d