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
4465–4488 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 29, 2013
PACIFIC PLUS
K123358 · LIT
Medtronic Vascular
Cardiovascular · 90d
Cleared Jan 29, 2013
PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY
K123067 · DQX
Abbott Vascular, Inc.
Cardiovascular · 120d
Cleared Jan 29, 2013
HEARTSPAN STEERABLE INTRODUCER KIT
K122431 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 172d
Cleared Jan 28, 2013
AXERA 2 ACCESS SYSTEM MODEL AXE200
K123135 · DYB
Arstasis, Inc.
Cardiovascular · 115d
Cleared Jan 25, 2013
2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035
K123632 · MCW
Spectranetics Corp.
Cardiovascular · 63d
Cleared Jan 25, 2013
ESA615
K121860 · DRT
Fluke Biomedical
Cardiovascular · 213d
Cleared Jan 24, 2013
REPROCESSED STEERABLE INTRODUCER
K123334 · DYB
Stryker Sustainability Solutions, Inc.
Cardiovascular · 90d
Cleared Jan 24, 2013
SUREFLEX STEERABLE GUIDING SHEATH KIT
K122926 · DYB
Baylis Medical Co., Inc.
Cardiovascular · 122d
Cleared Jan 22, 2013
AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA...
K123314 · DTZ
Medtronic, Inc.
Cardiovascular · 89d
Cleared Jan 18, 2013
VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE
K123813 · OBJ
Vasonova, Inc.
Cardiovascular · 38d
Cleared Jan 17, 2013
WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS
K123946 · DWJ
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 27d
Cleared Jan 17, 2013
CRUX VENA CAVA FILTER SYSTEM
K122585 · DTK
Crux Biomedical
Cardiovascular · 146d
Cleared Jan 16, 2013
WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM
K123671 · DRG
Sanitas, Inc.
Cardiovascular · 48d
Cleared Jan 16, 2013
MERIT HYDROPHILIC GUIDE WIRE
K123609 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 56d
Cleared Jan 16, 2013
DK-PTCA BALLOON CATHETER
K123264 · LOX
Intuit Medical, LLC
Cardiovascular · 90d
Cleared Jan 15, 2013
VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS
K122873 · JOW
Caremed Supply, Inc.
Cardiovascular · 118d
Cleared Jan 14, 2013
QXMEDICAL ACCESS & SUPPORT CATHETER
K123311 · DQY
Qxmedical, LLC
Cardiovascular · 81d
Cleared Jan 11, 2013
WA SERIES: WA100
K123839 · DXN
Ningbo Diaier Electronic Co., Ltd.
Cardiovascular · 29d
Cleared Jan 11, 2013
SELECTRA 7F CATHETERS
K123324 · DQY
Biotronik, Inc.
Cardiovascular · 77d
Cleared Jan 11, 2013
PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO
K123048 · MHX
Advanced Instrumentations, Inc.
Cardiovascular · 105d
Cleared Jan 11, 2013
HD-IVUS ULTRASOUND IMAGING SYSTEM
K122878 · OBJ
Silicon Vally Medical Instruments, Inc.
Cardiovascular · 114d
Cleared Jan 11, 2013
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K122685 · PNO
Angioscore, Inc.
Cardiovascular · 133d
Cleared Jan 11, 2013
TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT
K122576 · MJN
Stryker Neurovascular
Cardiovascular · 141d
Cleared Jan 09, 2013
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL...
K122914 · DTN
Medtronic, Inc.
Cardiovascular · 110d