Cardiac Assist Inc

FDA Filings

This page includes the latest FDA filings for Cardiac Assist 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
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 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 K162214 CARDIAC ASSIST, INC.	Protek Solo 24 Fr Venous Cannula Set	2016-11-30
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
PMN K160257 CARDIAC ASSIST, INC.	PROTEK Duo 31 Fr. Veno-Venous Cannula Set	2016-03-04
PMN K153295 CARDIAC ASSIST, INC.	TandemLung Oxygenator	2016-02-26
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 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 K133236 CARDIAC ASSIST, INC.	TANDEMHEART FEMORAL VENOUS CANNULA SET	2014-01-29
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 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 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 K082425 CARDIAC ASSIST, INC.	TANDEMHEART TRANSSEPTAL CANNULA- EF 72	2008-09-18
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
PMN K061369 CARDIAC ASSIST, INC.	TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500	2006-08-22
PMN K052570 CARDIAC ASSIST, INC.	TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221	2006-01-17
PMN K030398 CARDIAC ASSIST, INC.	CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221	2003-05-23
PMN K991783 CARDIAC ASSIST, INC.	AB-180 XC SYSTEM, MODEL AB-180XC	2000-11-01

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