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
11497–11520 of 18,027
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 22, 1993
LONG LENGTH PERCUTANEOUS INTRODUCER SET
K924456 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 201d
Cleared Mar 18, 1993
SHILEY PERFUSION TUBING SETS
K920594 · DTM
Shiley, Inc.
Cardiovascular · 401d
Cleared Mar 18, 1993
MODEL 1300 SOFTRACE II ELECTRODE
K921164 · DRX
Medtronic Vascular
Cardiovascular · 372d
Cleared Mar 18, 1993
ANGEION IGITAL ANGEFLATOR
K921757 · MAV
Angeion Corp.
Cardiovascular · 339d
Cleared Mar 18, 1993
HPM 40 HEART PACEMAKER MONITOR
K922742 · KRE
Biotronik, GmbH & Co.
Cardiovascular · 283d
Cleared Mar 18, 1993
ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE
K924338 · DRC
Arrow Intl., Inc.
Cardiovascular · 203d
Cleared Mar 12, 1993
SARNS RETROGRADE CANNULA - AUTO INFLATE
K922471 · DWF
3M Health Care, Sarns
Cardiovascular · 290d
Cleared Mar 11, 1993
RETRIEVER 10
K921649 · DQO
Target Therapeutics
Cardiovascular · 339d
Cleared Mar 08, 1993
FLOW CONROL VALVE
K922781 · MJJ
American Omni Medical, Inc.
Cardiovascular · 272d
Cleared Mar 08, 1993
KING OF HEARTS SCEPTER
K923221 · DPS
Instromedix, Inc.
Cardiovascular · 250d
Cleared Mar 08, 1993
INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION
K923603 · DYB
Kontron Instruments, Inc.
Cardiovascular · 249d
Cleared Mar 04, 1993
WELTER SNARE RETRIEVER
K920823 · DXE
Cook, Inc.
Cardiovascular · 374d
Cleared Mar 04, 1993
ATLANTIS GUI
K924575 · MHX
Hospitronics
Cardiovascular · 175d
Cleared Mar 03, 1993
PRIMEDIC DEFIBRILLATORS-N/B
K921765 · LDD
Metronic Electronic GmbH
Cardiovascular · 323d
Cleared Mar 03, 1993
MORSE(R) ANGIOGRAPHIC CATHETERS
K922552 · DQO
North American Instrument Corp.
Cardiovascular · 278d
Cleared Mar 02, 1993
SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES
K920445 · MHX
Siemens Medical Electronics
Cardiovascular · 392d
Cleared Mar 01, 1993
USCI LUMISILK GUIDE WIRE WITH PRO/PEL COATING
K925074 · DQX
C.R. Bard, Inc.
Cardiovascular · 145d
Cleared Feb 26, 1993
J-LLOYD ARTERIAL EMBOLECTOMY CATHETER
K920871 · DXE
J-Lloyd Medical, Inc.
Cardiovascular · 367d
Cleared Feb 25, 1993
DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101
K922009 · DSA
Remington Medical, Inc.
Cardiovascular · 302d
Cleared Feb 25, 1993
WITT BIOMEDICAL SERIES II-EP
K923054 · MHX
Witt Biomedical Corporation
Cardiovascular · 246d
Cleared Feb 25, 1993
CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE
K924554 · LYK
Clarus Medical Systems, Inc.
Cardiovascular · 169d
Cleared Feb 25, 1993
CATHETER INTRODUCER
K924562 · DYB
Luther Medical Products, Inc.
Cardiovascular · 169d
Cleared Feb 25, 1993
MODEL 2041-PC/ST CARDIAC TELEMETRY MONITOR
K925411 · DSI
Accucore, Inc.
Cardiovascular · 122d
Cleared Feb 25, 1993
SERIES 1500 DEFIBRILLATOR, MODIFICATION
K926172 · MKJ
Marquette Electronics, Inc.
Cardiovascular · 86d