Cardiacassist Inc

FDA Filings

This page includes the latest FDA filings for Cardiacassist Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 2531527
• FEI Number: 3002228812
• Name: CARDIAC ASSIST, INC.
• Owner & Operator: CardiacAssist, Inc. dba TandemLife
• Contact Address: 620 ALPHA DR. ; Pittsburgh PA 15238 US
• Official Correspondent:
  • Megan Walsh
  • x-412-2307324-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 620 Alpha Dr ; Pittsburgh, PA 15238 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00814112020678 CARDIACASSIST, INC.	LifeSPARC	2024-08-15
GUDID 00814112020586 CARDIACASSIST, INC.	LifeSPARC	2023-03-06
GUDID 00814112020708 CARDIACASSIST, INC.	TandemLife LifeSPARC	2022-08-05
GUDID 00814112020692 CARDIACASSIST, INC.	TandemLife LifeSPARC	2022-08-05
GUDID 00814112020906 CARDIACASSIST, INC.	LifeSPARC 5900-0012	2022-05-18
PMN K202751 CardiacAssist, Inc.	TandemHeart Pump And Escort Controller	2021-03-26
GUDID 00814112020814 CARDIACASSIST, INC.	LifeSPARC	2020-06-08
GUDID 00814112020777 CARDIACASSIST, INC.	TandemLung LifeSPARC	2020-06-08
GUDID 00814112020760 CARDIACASSIST, INC.	TandemLung LifeSPARC	2020-06-08
GUDID 00814112020753 CARDIACASSIST, INC.	TandemLung LifeSPARC	2020-06-08
GUDID 00814112020685 CARDIACASSIST, INC.	TandemLife LifeSPARC	2020-06-08
GUDID 00814112020609 CARDIACASSIST, INC.	LifeSPARC	2020-06-08
GUDID 00814112020555 CARDIACASSIST, INC.	ProtekDuo	2020-01-22
GUDID 00814112020524 CARDIACASSIST, INC.	TandemLife	2020-01-22
GUDID 00814112020517 CARDIACASSIST, INC.	TandemLife	2020-01-22
GUDID 00814112020494 CARDIACASSIST, INC.	TandemLife	2020-01-22
GUDID 00814112020470 CARDIACASSIST, INC.	TandemLife	2020-01-22
GUDID 00814112020432 CARDIACASSIST, INC.	TandemLung	2020-01-22
GUDID 00814112020425 CARDIACASSIST, INC.	TandemLung	2020-01-22
GUDID 00814112020241 CARDIACASSIST, INC.	TandemLung	2020-01-22
GUDID 00814112020807 CARDIACASSIST, INC.	LifeSPARC	2019-12-26
GUDID 00814112020791 CARDIACASSIST, INC.	LifeSPARC	2019-12-26
GUDID 00814112020784 CARDIACASSIST, INC.	LifeSPARC	2019-12-26
GUDID 00814112020746 CARDIACASSIST, INC.	LifeSPARC	2019-12-26
GUDID 00814112020739 CARDIACASSIST, INC.	LifeSPARC	2019-12-26
GUDID 00814112020722 CARDIACASSIST, INC.	LifeSPARC	2019-12-26
GUDID 00814112020715 CARDIACASSIST, INC.	LifeSPARC	2019-12-26
GUDID 00814112020654 CARDIACASSIST, INC.	LifeSPARC	2019-12-26
GUDID 00814112020647 CARDIACASSIST, INC.	LifeSPARC	2019-12-26
GUDID 00814112020616 CARDIACASSIST, INC.	LifeSPARC	2019-12-26
GUDID 00814112020593 CARDIACASSIST, INC.	LifeSPARC	2019-12-26
GUDID 00814112020579 CARDIACASSIST, INC.	LifeSPARC	2019-12-26
GUDID 00814112020562 CARDIACASSIST, INC.	LifeSPARC	2019-12-26
PMN K183623 | KFM CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	LifeSPARC System	2019-11-18
PMN K183623 | DWA CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	LifeSPARC System	2019-11-18
PMN K183623 CardiacAssist Inc	LifeSPARC Pump, LifeSPARC Controller	2019-07-09
GUDID 00814112020548 CARDIACASSIST, INC.	ProtekDuo	2018-11-08
GUDID 00814112020531 CARDIACASSIST, INC.	ProtekDuo	2018-11-01
GUDID 00814112020500 CARDIACASSIST, INC.	TandemLife	2018-10-03
GUDID 00814112020463 CARDIACASSIST, INC.	ProtekSolo	2018-10-03
GUDID 00814112020456 CARDIACASSIST, INC.	ProtekDuo	2018-10-03
GUDID 00814112020449 CARDIACASSIST, INC.	ProtekSolo	2018-10-03
GUDID 00814112020418 CARDIACASSIST, INC.	ProtekDuo	2018-10-03
GUDID 00814112020401 CARDIACASSIST, INC.	ProtekDuo	2018-10-03
GUDID 00814112020395 CARDIACASSIST, INC.	TandemHeart	2018-10-03
GUDID 00814112020388 CARDIACASSIST, INC.	TandemHeart	2018-10-03
GUDID 00814112020371 CARDIACASSIST, INC.	TandemHeart	2018-10-03
GUDID 00814112020364 CARDIACASSIST, INC.	TandemHeart	2018-10-03
GUDID 00814112020319 CARDIACASSIST, INC.	ProtekDuo	2018-10-03
GUDID 00814112020296 CARDIACASSIST, INC.	VOYAGER	2018-10-03
GUDID 00814112020289 CARDIACASSIST, INC.	VOYAGER	2018-10-03
GUDID 00814112020265 CARDIACASSIST, INC.	TandemHeart	2018-10-03
GUDID 00814112020234 CARDIACASSIST, INC.	TandemHeart- TRIS	2018-10-03
GUDID 00814112020180 CARDIACASSIST, INC.	TandemHeart	2018-10-03
GUDID 00814112020173 CARDIACASSIST, INC.	PROTEK Duo	2018-10-03
GUDID 00814112020166 CARDIACASSIST, INC.	PROTEK Duo	2018-10-03
GUDID 00814112020135 CARDIACASSIST, INC.	TandemHeart-TRIS	2018-10-03
GUDID 00814112020128 CARDIACASSIST, INC.	TandemHeart-TRIS	2018-10-03
GUDID 00814112020111 CARDIACASSIST, INC.	TandemHeart	2018-10-03
GUDID 00814112020104 CARDIACASSIST, INC.	TandemHeart	2018-10-03
GUDID 00814112020098 CARDIACASSIST, INC.	TandemHeart	2018-10-03
GUDID 00814112020067 CARDIACASSIST, INC.	TandemHeart	2018-10-03
GUDID 00814112020050 CARDIACASSIST, INC.	TandemHeart	2018-10-03
GUDID 00814112020043 CARDIACASSIST, INC.	TandemHeart	2018-10-03
GUDID 00814112020036 CARDIACASSIST, INC.	TandemHeart	2018-10-03
GUDID 00814112020029 CARDIACASSIST, INC.	TandemHeart	2018-10-03
GUDID 00814112020012 CARDIACASSIST, INC.	TandemHeart	2018-10-03
GUDID 00814112020005 CARDIACASSIST, INC.	TandemHeart	2018-10-03
PMN K181150 CardiacAssist Inc	ProtekDuo Mini Veno-Venous Cannula Set	2018-05-25
PMN K162214 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	Protek Solo 24 Fr Venous Cannula	2017-01-26
PMN K162181 | DRE CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	Protek Venous Dilator Set	2017-01-26
PMN K162181 CARDIACASSIST INC.	Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set	2017-01-06
PMN K160257 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart Veno-Venous Cannula	2016-09-22
PMN K160257 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart ProtekDUO Cannula	2016-09-22
PMN K160257 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart Dual Lumen Cannula	2016-09-22
PMN K160257 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	THVVC	2016-09-22
PMN K160257 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	THDLC	2016-09-22
PMN K160257 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	ProtekDUO	2016-09-22
PMN K153295 | DTZ CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemLung Oxygenator	2016-04-05
KRI CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart Wrap	2015-10-08
KRI CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart Vest	2015-10-08
KRI CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart Vest - Pump and Oxygenator	2015-10-08
KRI CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart Vest - Pump Only	2015-10-08
KRI CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart Pump Holster	2015-10-08
PMN K140999 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart Veno-Venous Cannula	2014-09-25
PMN K140999 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart ProtekDUO Cannula	2014-09-25
PMN K140999 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart Dual Lumen Cannula	2014-09-25
PMN K140999 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	THVVC	2014-09-25
PMN K140999 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	THDLC	2014-09-25
PMN K140999 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	ProtekDUO	2014-09-25
PMN K140999 CARDIACASSIST INC.	TANDEMHEART VENO-VENOUS CANNULA	2014-08-06
PMN K133293 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart PROTEK15 Arterial Cannula	2014-07-08
PMN K133293 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart Arterial Cannula - 15 Fr	2014-07-08
PMN K133293 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	THAC-15	2014-07-08
PMN K133293 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	PROTEK15	2014-07-08
PMN K133236 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart Venous Cannula	2014-07-08
PMN K133236 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	THVC	2014-07-08
PMN K133293 CARDIACASSIST INC.	15 FR. TANDEMHEART ARTERIAL CANNULA	2014-02-12
PMN K120543 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart?PROTEK17 Arterial Cannula	2012-11-05
PMN K120543 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart Arterial Cannula	2012-11-05
PMN K120543 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	THAC	2012-11-05
PMN K120543 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	PROTEK17 Arterial Cannula	2012-11-05
PMN K120543 CARDIACASSIST INC.	TANDEMHEART FEMORAL ARTERIAL CANNULA SET	2012-05-30
PMN K110493 | KFM CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart System	2012-04-02
PMN K110493 | KFM CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart Escort Controller	2012-04-02
PMN K110493 | KFM CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart Blood Pump	2012-04-02
PMN K110493 CARDIACASSIST INC.	TANDEMHEART PUMP	2011-09-20
PMN K082425 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	Transseptal Cannula Set 72 CM	2008-10-09
PMN K082425 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart Transseptal Cannula Set 72 CM - Enhanced Flow	2008-10-09
PMN K082425 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	THTC-EF 72	2008-10-09
PMN K991783 | KFM CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart XD Controller	2007-12-11
PMN K991783 | KFM CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart System Controller	2007-12-11
PMN K991783 | KFM CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart Pump	2007-12-11
PMN K991783 | KFM CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart Blood Pump	2007-12-11
PMN K061369 | DWA CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart System	2007-12-11
PMN K061369 | DWA CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart Escort Controller	2007-12-11
PMN K061369 | DWA CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart Blood Pump	2007-12-11
PMN K052570 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart Transseptal Cannula Set	2007-12-11
PMN K052570 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart Transseptal Cannula Set - Enhanced Flow	2007-12-11
PMN K052570 | DWF CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	THTC-EF	2007-12-11
PMN K030398 | DQR CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	Transseptal Cannula Set	2007-12-11
PMN K030398 | DQR CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	TandemHeart?Transseptal Cannula Set	2007-12-11
PMN K030398 | DQR CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]	THTC	2007-12-11

Related Finance Registrations

NCAGE Code	4K3R7	CARDIACASSIST, INC.
CAGE Code	4K3R7	CARDIACASSIST, INC.
S.A.M. Registration	4K3R7 [948683941]	CARDIACASSIST, INC.
SEC	0001131718	CARDIACASSIST INC