FDA.reportPublic FDA data

CARDIAC ASSIST, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
25315273002228812CARDIAC ASSIST, INC.1N2020-04-25620 Alpha Dr Pittsburgh PA US 15238

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
529061416701045K991783AB-180 XC SYSTEM, MODEL AB-180XCKFM2000-11-01
529061185191221K183623LifeSPARC Pump, LifeSPARC ControllerKFM2019-07-09
529061324229190K181150ProtekDuo Mini Veno-Venous Cannula SetDWF2018-05-25
529061580320117K162214Protek Solo 24 Fr Venous Cannula SetDWF2016-11-30
529061738730883K162181Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetDRE2017-01-06
529061074305003K160257PROTEK Duo 31 Fr. Veno-Venous Cannula SetDWF2016-03-04
529062035197119K153295TandemLung OxygenatorDTZ2016-02-26
529061350292258K140999TANDEMHEART VENO-VENOUS CANNULADWF2014-08-06
529061638734379K13329315 FR. TANDEMHEART ARTERIAL CANNULADWF2014-02-12
529061761693357K133236TANDEMHEART FEMORAL VENOUS CANNULA SETDWF2014-01-29
529061662942555K120543TANDEMHEART FEMORAL ARTERIAL CANNULA SETDWF2012-05-30
529061824560944K110493TANDEMHEART PUMPKFM2011-09-20
529061343400075K082425TANDEMHEART TRANSSEPTAL CANNULA- EF 72DWF2008-09-18
529061463517430K061369TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500DWA2006-08-22
529061213675945K052570TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221DWF2006-01-17
529061637874415K030398CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221DQR2003-05-23
529061429975417

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DWF92018-05-25
KFM32019-07-09
DRE12017-01-06
DTZ12016-02-26
DWA12006-08-22
DQR12003-05-23

PMN#