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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
8689–8712 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 07, 2001
IMAGER II ANGIOGRAPHIC CATHETER
K011664 · DQO
Boston Scientific/Medi-Tech
Cardiovascular · 100d
Cleared Sep 06, 2001
DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE
K011361 · DRF
Catheffects, LLC
Cardiovascular · 126d
Cleared Sep 06, 2001
VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
K012050 · DQY
Guidant Corp.
Cardiovascular · 66d
Cleared Sep 05, 2001
MICROCRUISER PLUS INTRODUCER SET
K011790 · DYB
Medical Device Technologies, Inc.
Cardiovascular · 89d
Cleared Sep 04, 2001
PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS
K003548 · MKJ
Padpro, LLC
Cardiovascular · 291d
Cleared Sep 04, 2001
NEXAN SYSTEM, MODEL NX-301
K010424 · MWI
Nexan, Ltd.
Cardiovascular · 203d
Cleared Sep 04, 2001
DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260
K012392 · DSA
Pace Medical
Cardiovascular · 39d
Cleared Aug 30, 2001
SENSI-PREMA NEONATAL ECG ELECTRODES,...
K003804 · DRX
Niko Medical Products
Cardiovascular · 265d
Cleared Aug 30, 2001
SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000
K011729 · DTC
Dni Nevada, Inc.
Cardiovascular · 87d
Cleared Aug 30, 2001
ILT SUPPORT CATHETER .014, MODEL C114LW1
K012169 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 49d
Cleared Aug 30, 2001
MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH...
K012489 · DYB
Appriva Medical, Inc.
Cardiovascular · 27d
Cleared Aug 28, 2001
SNIPER ELITE MODEL-OR-E3872XX SERIES
K011905 · DQX
Maxxim Medical
Cardiovascular · 70d
Cleared Aug 28, 2001
ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218
K012083 · DQY
Medtronic Vascular
Cardiovascular · 56d
Cleared Aug 28, 2001
ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM
K012130 · DQY
Medtronic Vascular
Cardiovascular · 50d
Cleared Aug 28, 2001
ATTAIN 6215 VENOGRAM BALLOON CATHETER
K012225 · DYG
Medtronic Vascular
Cardiovascular · 43d
Cleared Aug 27, 2001
NEUROEDGE INFUSION CATHETER
K011646 · KRA
Neuro Vasx, Inc.
Cardiovascular · 90d
Cleared Aug 23, 2001
LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM
K010918 · MKJ
Medtronic Physio-Control Corp.
Cardiovascular · 149d
Cleared Aug 23, 2001
TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE
K012538 · DWF
Medtronic Vascular
Cardiovascular · 16d
Cleared Aug 22, 2001
MONARCH INFLATION SYRINGE
K011811 · DXT
Merit Medical Systems, Inc.
Cardiovascular · 72d
Cleared Aug 22, 2001
MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR
K012310 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Aug 21, 2001
KSEA DION-GRACIA SET
K010785 · DXC
KARL STORZ Endoscopy-America, Inc.
Cardiovascular · 159d
Cleared Aug 21, 2001
WECK CARDIAC PACING WIRES
K011660 · LDF
Weck Closure Systems
Cardiovascular · 84d
Cleared Aug 21, 2001
MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR
K011991 · DXT
Medrad, Inc.
Cardiovascular · 56d
Cleared Aug 21, 2001
RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC
K012020 · DQK
Non-Invasive Monitoring Systems, Inc.
Cardiovascular · 54d