CARDIAC ASSIST, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2531527	3002228812	CARDIAC ASSIST, INC.	1	N	2020-04-25	620 Alpha Dr Pittsburgh PA US 15238

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
52906	1416701045	K991783	AB-180 XC SYSTEM, MODEL AB-180XC	KFM	2000-11-01
52906	1185191221	K183623	LifeSPARC Pump, LifeSPARC Controller	KFM	2019-07-09
52906	1324229190	K181150	ProtekDuo Mini Veno-Venous Cannula Set	DWF	2018-05-25
52906	1580320117	K162214	Protek Solo 24 Fr Venous Cannula Set	DWF	2016-11-30
52906	1738730883	K162181	Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set	DRE	2017-01-06
52906	1074305003	K160257	PROTEK Duo 31 Fr. Veno-Venous Cannula Set	DWF	2016-03-04
52906	2035197119	K153295	TandemLung Oxygenator	DTZ	2016-02-26
52906	1350292258	K140999	TANDEMHEART VENO-VENOUS CANNULA	DWF	2014-08-06
52906	1638734379	K133293	15 FR. TANDEMHEART ARTERIAL CANNULA	DWF	2014-02-12
52906	1761693357	K133236	TANDEMHEART FEMORAL VENOUS CANNULA SET	DWF	2014-01-29
52906	1662942555	K120543	TANDEMHEART FEMORAL ARTERIAL CANNULA SET	DWF	2012-05-30
52906	1824560944	K110493	TANDEMHEART PUMP	KFM	2011-09-20
52906	1343400075	K082425	TANDEMHEART TRANSSEPTAL CANNULA- EF 72	DWF	2008-09-18
52906	1463517430	K061369	TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500	DWA	2006-08-22
52906	1213675945	K052570	TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221	DWF	2006-01-17
52906	1637874415	K030398	CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221	DQR	2003-05-23
52906	1429975417

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DWF	9	2018-05-25
KFM	3	2019-07-09
DRE	1	2017-01-06
DTZ	1	2016-02-26
DWA	1	2006-08-22
DQR	1	2003-05-23