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
6793–6816 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 13, 2006
HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR
K061070 · DRC
Hansen Medical, Inc.
Cardiovascular · 179d
Cleared Oct 12, 2006
ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810
K062144 · MHX
Invivo Corporation
Cardiovascular · 77d
Cleared Oct 12, 2006
CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND...
K061046 · NQH
Cardiomems, Inc.
Cardiovascular · 181d
Cleared Oct 06, 2006
FLEXITOUCH SYSTEM
K062818 · JOW
Tactile Systems Technology, Inc.
Cardiovascular · 16d
Cleared Oct 06, 2006
MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
K062609 · DQY
AngioDynamics, Inc.
Cardiovascular · 31d
Cleared Oct 06, 2006
CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES
K060927 · DQY
Ceres Medical Systems, LLC
Cardiovascular · 185d
Cleared Oct 05, 2006
SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM
K062387 · PNO
Boston Scientific
Cardiovascular · 51d
Cleared Oct 05, 2006
TREASURE
K061984 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 84d
Cleared Oct 05, 2006
VASORING* VRC VASCULAR RING CONNECTOR
K061626 · DSY
Sunwei Tech Co. , Ltd.
Cardiovascular · 115d
Cleared Oct 05, 2006
OPTICATH CENTRAL VENOUS OXIMETRY CATHETER
K061585 · DQE
Hospira, Inc.
Cardiovascular · 120d
Cleared Sep 29, 2006
DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM...
K062576 · MHX
Ge Healthcare
Cardiovascular · 29d
Cleared Sep 29, 2006
NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L
K062462 · DXN
Jawon Medical Co., Ltd.
Cardiovascular · 36d
Cleared Sep 29, 2006
DLM112 DAYLINK MONITOR
K062304 · DRG
Rtx Healthcare A/S
Cardiovascular · 52d
Cleared Sep 29, 2006
MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
K062095 · MHX
Spacelabs Medical, Inc.
Cardiovascular · 67d
Cleared Sep 29, 2006
CLIRPATH TURBO PERIPHERAL CATHETERS
K060012 · PDU
Spectranetics Corp.
Cardiovascular · 269d
Cleared Sep 28, 2006
MODIFICATION TO LUCAS
K062401 · DRM
Jolife AB
Cardiovascular · 43d
Cleared Sep 28, 2006
MODIFICATION TO STOCKERT S5 SYSTEM
K062396 · DTQ
Sorin Group Deutschland GmbH
Cardiovascular · 43d
Cleared Sep 27, 2006
MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE,...
K062429 · DTM
Edwards Lifesciences Research Medical
Cardiovascular · 37d
Cleared Sep 25, 2006
TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT
K062342 · DRS
Sentra Medical Devices, LLC
Cardiovascular · 45d
Cleared Sep 25, 2006
SCD GARMENT, MODEL VP530
K061967 · JOW
Compression Therapy Concepts, Inc.
Cardiovascular · 75d
Cleared Sep 22, 2006
ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE...
K062531 · NTE
Cordis Corp., A Johnson & Johnson Co.
Cardiovascular · 24d
Cleared Sep 22, 2006
HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100
K062119 · DRM
Medical Products Mfg., LLC
Cardiovascular · 59d
Cleared Sep 21, 2006
TYTAN BLOOD PRESSURE CUFF
K062238 · DXQ
Tytan Medical Corp.
Cardiovascular · 50d
Cleared Sep 20, 2006
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
K062594 · DQY
Boston Scientific Corporation
Cardiovascular · 19d