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
12073–12096 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 29, 1991
BARD PERIPHERAL BALLOON DILATATION CATHETER
K910822 · LIT
C.R. Bard, Inc.
Cardiovascular · 184d
Cleared Aug 29, 1991
EDENTEC MODEL 3711 DIGITAL RECORDER
K910870 · DRT
Edentec Corp.
Cardiovascular · 181d
Cleared Aug 29, 1991
EDENTEC DIGITAL CHARTER MODEL 3710
K910871 · DSF
Edentec Corp.
Cardiovascular · 181d
Cleared Aug 29, 1991
ESCORT 300 SERIES
K911665 · LDD
Medical Data Electronics
Cardiovascular · 139d
Cleared Aug 28, 1991
MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR
K897068 · DTZ
Medtronic Vascular
Cardiovascular · 615d
Cleared Aug 28, 1991
THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER
K901281 · DRB
Val-Mark Medical, Inc.
Cardiovascular · 527d
Cleared Aug 28, 1991
PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP
K910609 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 197d
Cleared Aug 28, 1991
ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE
K910924 · DTB
Pacesetter Systems
Cardiovascular · 176d
Cleared Aug 28, 1991
100 CM PERMANENT PACING LEAD MODELS
K911273 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 159d
Cleared Aug 28, 1991
TRACETS SME 5000
K912450 · DRX
Lectec Corp.
Cardiovascular · 86d
Cleared Aug 22, 1991
MONARCH SYSTEM
K911051 · MHX
Baxter Healthcare Corp
Cardiovascular · 167d
Cleared Aug 22, 1991
BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP
K911351 · DXN
Biochem International, Inc.
Cardiovascular · 148d
Cleared Aug 22, 1991
SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO PTA CATH
K912317 · LIT
Schneider Intl., Ltd.
Cardiovascular · 90d
Cleared Aug 22, 1991
MODEL 4220
K913134 · DXY
Pace Medical
Cardiovascular · 37d
Cleared Aug 21, 1991
MODEL SCR-1000
K913400 · DXH
Accucore, Inc.
Cardiovascular · 22d
Cleared Aug 20, 1991
MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT
K911789 · DTP
Medtronic Vascular
Cardiovascular · 120d
Cleared Aug 20, 1991
SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION
K912078 · DTZ
3M Health Care, Sarns
Cardiovascular · 102d
Cleared Aug 19, 1991
MR-5200 FULL DISCLOSURE SYSTEM
K911257 · DSH
Mennen Medical, Inc.
Cardiovascular · 151d
Cleared Aug 16, 1991
OPTI-PLAST 5F PTA CATHETERS
K913112 · LIT
Vas-Cath, Inc.
Cardiovascular · 42d
Cleared Aug 15, 1991
VER-MED A10014 RESTING EKG ELECTRODE & A10021
K910139 · DRX
Vermont Medical, Inc.
Cardiovascular · 213d
Cleared Aug 13, 1991
LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2)
K911763 · DPW
Vasamedics, LLC
Cardiovascular · 116d
Cleared Aug 13, 1991
DASH IV
K912929 · DSF
Astro-Med, Inc.
Cardiovascular · 39d
Cleared Aug 13, 1991
OPTI-PLAST 5F PTA CATHETERS, MODIFICATION
K912984 · LIT
Vas-Cath, Inc.
Cardiovascular · 46d
Cleared Aug 12, 1991
MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG
K911790 · DTN
Medtronic Vascular
Cardiovascular · 112d