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THORATEC CORP

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12184441218444THORATEC CORP1N2026-01-0123 4th Ave BURLINGTON MA US 01803

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2164141169765554P870072THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEMDSQ1995-12-20
2164141268771950P170038CentriMag Circulatory Support SystemDSQ2019-12-06
2164141693005481P160054HeartMate 3™ Left Ventricular Assist SystemDSQ2017-08-23
2164141150101011P060040THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEMDSQ2008-04-21
2164141507592993K234118CentriMag™ Acute Circulatory Support SystemQNR2024-01-26
2164141807233330K222297CentriMag Pre-connected PackDTZ2022-12-01
2164141542722552K222038CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support SystemQNR2022-12-08
2164142072640974K102129LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITORDWA2010-08-27
2164141765813038K090051LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052KFM2009-10-08
2164141486203148K020271LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100KFM2003-03-25
2164141850234297H070004
2164141237972502

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DSQ32017-08-23
QNR22024-01-26
KFM22009-10-08
DTZ12022-12-01
DSQ 12019-12-06
DWA12010-08-27

PMN#