FDA.reportPublic FDA data

SENTREHEART INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30058022383006482885SENTREHEART INC.1N2020-04-25300 Saginaw Dr Redwood City CA US 94063

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
M95520060EndoCATH - Large Occlusion Balloon Catheter1-855-256-7330info@sentreheart.com
M95530050Lariat - Suture Delivery Device1-855-256-7330info@sentreheart.com
M95530060Lariat - Suture Delivery Device650 354 1200info@sentreheart.com
M95550010SureCUT - A sterile, hand-held surgical instrument designed for cutting sutures using a mechanical action. It typically has a protected scalpel-like blade or a scissors-like cutting end, and a proximal manual actuator. This is a single-use device.650-354-1200info@sentreheart.com
M95560020SofTIP - A sterile tube-like device intended to facilitate the use of an open-surgery ligature loop ligator by guiding and protecting its passage through other tissues. It is made of plastic materials. This is a single-use device.650-354-1200info@sentreheart.com
M95580020Tensure - A sterile, manual, hand-held surgical device intended for controlled tightening of a ligature loop in situ (e.g., during vascular surgery). The ligature is intended to be loaded into the device, which typically includes a sliding mechanism, allowing controlled manual tightening; the device may also include tightening markers. This is a single-use device650-354-1200info@sentreheart.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2350391234687945K153096LARIAT RS Suture Delivery DeviceGAT2015-11-25
2350391428898645K142241LARIAT sulture Delivery DeviceGAT2014-09-12
2350392055779782K090385LARIAT II SUTURE DELIVERY DEVICEGAT2009-05-06
2350391544752783K080364FINDRWIRZ GUIDE WIRE SYSTEMDQX2008-08-11
2350391738849252K070126OCCLUSION BALLOON CATHETERDQY2008-02-08
2350391356122521
2350391651111601

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GAT32015-11-25
DQX12008-08-11
DQY12008-02-08

PMN#

GUDID#