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
12409–12432 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 06, 1990
SOFTSHELL VENOUS RESERVOIR
K904040 · DTN
C.R. Bard, Inc.
Cardiovascular · 93d
Cleared Dec 06, 1990
SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM
K904171 · DTR
Scimed
Cardiovascular · 86d
Cleared Dec 06, 1990
GUIDEWIRE
K904477 · DQX
Datascope Corp.
Cardiovascular · 66d
Cleared Dec 05, 1990
VAS-CATH OPTI-PLAST 5F PERIPHERAL ANGIOPLASTY CATH
K903417 · LIT
Vas-Cath, Inc.
Cardiovascular · 127d
Cleared Dec 05, 1990
MICROMED QRS CARD
K903722 · DPS
Nasiff Assoc., Inc.
Cardiovascular · 112d
Cleared Dec 03, 1990
KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM
K896437 · DPT
Kontron Instruments, Inc.
Cardiovascular · 389d
Cleared Dec 03, 1990
ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE
K900560 · DQC
Acuson Corp.
Cardiovascular · 299d
Cleared Dec 03, 1990
AMPLATZ GOOSE-NECK SNARE
K901502 · DXE
Microvena Corp.
Cardiovascular · 249d
Cleared Dec 03, 1990
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATH.
K902317 · LIT
Mallinckrodt Medical
Cardiovascular · 194d
Cleared Dec 03, 1990
OPTI-PLAST 7F PERIPHERAL ANGIOPLASTY CATHETER
K902367 · LIT
Vas-Cath, Inc.
Cardiovascular · 188d
Cleared Dec 03, 1990
CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS
K902475 · DXT
Cardio-Pak
Cardiovascular · 182d
Cleared Dec 03, 1990
SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH
K902587 · DQY
Schneider Intl., Ltd.
Cardiovascular · 174d
Cleared Dec 03, 1990
CORDIS CINCH(TM) STEER GUIDEWIRE EXTEN W/SLX COAT
K902612 · DQX
Cordis Corp.
Cardiovascular · 173d
Cleared Dec 03, 1990
DISPOSABLE INFLATION GAUGE
K902695 · MAV
Cook Urological, Inc.
Cardiovascular · 167d
Cleared Dec 03, 1990
GENTLE HEADER
K902845 · DWE
Enhanced Perfusion Systems, Inc.
Cardiovascular · 158d
Cleared Dec 03, 1990
MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MODEL 1220-002
K903018 · LDD
Medtronic Andover Medical, Inc.
Cardiovascular · 145d
Cleared Dec 03, 1990
OCHSNER 50 BIFURCATION
K903964 · DSY
Intervascular, Inc.
Cardiovascular · 97d
Cleared Dec 03, 1990
HIGH-PRESSURE CONNECTOR TUBE
K904212 · DXT
Mallinckrodt Medical
Cardiovascular · 82d
Cleared Dec 03, 1990
INFLATION/DEFLATION DEVICE
K904394 · MAV
Boston Scientific Corp
Cardiovascular · 69d
Cleared Dec 03, 1990
MODEL #210 STEALTH DEFIB PADS
K904462 · LDD
Cardiotronics, Inc.
Cardiovascular · 63d
Cleared Dec 03, 1990
PERCUTANEOUS INTRODUCER TRAY
K904608 · DQY
Thomas Medical Products, Inc.
Cardiovascular · 53d
Cleared Nov 21, 1990
USCI(R) SILK (TM) GUIDE WIRE
K903923 · DQX
C.R. Bard, Inc.
Cardiovascular · 89d
Cleared Nov 16, 1990
XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS.
K901514 · DSK
Ppg Industries, Inc.
Cardiovascular · 231d
Cleared Nov 16, 1990
DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER
K903437 · DRO
Keller Medical Specialties Products,...
Cardiovascular · 108d