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 Number2531527
FEI Number3002228812
NameCARDIAC ASSIST, INC.
Owner & OperatorCardiacAssist, Inc. dba TandemLife
Contact Address620 ALPHA DR.
Pittsburgh PA 15238 US
Official Correspondent
  • Megan Walsh
  • x-412-2307324-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address620 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
DeviceDate
CardiacAssist, Inc.
TandemHeart Pump And Escort Controller2021-03-26
CARDIACASSIST, INC.
LifeSPARC 2020-06-08
CARDIACASSIST, INC.
TandemLung LifeSPARC 2020-06-08
CARDIACASSIST, INC.
TandemLung LifeSPARC 2020-06-08
CARDIACASSIST, INC.
TandemLung LifeSPARC 2020-06-08
CARDIACASSIST, INC.
TandemLife LifeSPARC 2020-06-08
CARDIACASSIST, INC.
LifeSPARC 2020-06-08
CARDIACASSIST, INC.
ProtekDuo 2020-01-22
CARDIACASSIST, INC.
TandemLife 2020-01-22
CARDIACASSIST, INC.
TandemLife 2020-01-22
CARDIACASSIST, INC.
TandemLife 2020-01-22
CARDIACASSIST, INC.
TandemLife 2020-01-22
CARDIACASSIST, INC.
TandemLung 2020-01-22
CARDIACASSIST, INC.
TandemLung 2020-01-22
CARDIACASSIST, INC.
TandemLung 2020-01-22
CARDIACASSIST, INC.
LifeSPARC 2019-12-26
CARDIACASSIST, INC.
LifeSPARC 2019-12-26
CARDIACASSIST, INC.
LifeSPARC 2019-12-26
CARDIACASSIST, INC.
LifeSPARC 2019-12-26
CARDIACASSIST, INC.
LifeSPARC 2019-12-26
CARDIACASSIST, INC.
LifeSPARC 2019-12-26
CARDIACASSIST, INC.
LifeSPARC 2019-12-26
CARDIACASSIST, INC.
LifeSPARC 2019-12-26
CARDIACASSIST, INC.
LifeSPARC 2019-12-26
CARDIACASSIST, INC.
LifeSPARC 2019-12-26
CARDIACASSIST, INC.
LifeSPARC 2019-12-26
CARDIACASSIST, INC.
LifeSPARC 2019-12-26
CARDIACASSIST, INC.
LifeSPARC 2019-12-26
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
LifeSPARC System2019-11-18
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
LifeSPARC System2019-11-18
CardiacAssist Inc
LifeSPARC Pump, LifeSPARC Controller2019-07-09
CARDIACASSIST, INC.
ProtekDuo 2018-11-08
CARDIACASSIST, INC.
ProtekDuo 2018-11-01
CARDIACASSIST, INC.
TandemLife 2018-10-03
CARDIACASSIST, INC.
ProtekSolo 2018-10-03
CARDIACASSIST, INC.
ProtekDuo 2018-10-03
CARDIACASSIST, INC.
ProtekSolo 2018-10-03
CARDIACASSIST, INC.
ProtekDuo 2018-10-03
CARDIACASSIST, INC.
ProtekDuo 2018-10-03
CARDIACASSIST, INC.
TandemHeart 2018-10-03
CARDIACASSIST, INC.
TandemHeart 2018-10-03
CARDIACASSIST, INC.
TandemHeart 2018-10-03
CARDIACASSIST, INC.
TandemHeart 2018-10-03
CARDIACASSIST, INC.
ProtekDuo 2018-10-03
CARDIACASSIST, INC.
VOYAGER 2018-10-03
CARDIACASSIST, INC.
VOYAGER 2018-10-03
CARDIACASSIST, INC.
TandemHeart 2018-10-03
CARDIACASSIST, INC.
TandemHeart- TRIS 2018-10-03
CARDIACASSIST, INC.
TandemHeart 2018-10-03
CARDIACASSIST, INC.
PROTEK Duo 2018-10-03
CARDIACASSIST, INC.
PROTEK Duo 2018-10-03
CARDIACASSIST, INC.
TandemHeart-TRIS 2018-10-03
CARDIACASSIST, INC.
TandemHeart-TRIS 2018-10-03
CARDIACASSIST, INC.
TandemHeart 2018-10-03
CARDIACASSIST, INC.
TandemHeart 2018-10-03
CARDIACASSIST, INC.
TandemHeart 2018-10-03
CARDIACASSIST, INC.
TandemHeart 2018-10-03
CARDIACASSIST, INC.
TandemHeart 2018-10-03
CARDIACASSIST, INC.
TandemHeart 2018-10-03
CARDIACASSIST, INC.
TandemHeart 2018-10-03
CARDIACASSIST, INC.
TandemHeart 2018-10-03
CARDIACASSIST, INC.
TandemHeart 2018-10-03
CARDIACASSIST, INC.
TandemHeart 2018-10-03
CardiacAssist Inc
ProtekDuo Mini Veno-Venous Cannula Set2018-05-25
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
Protek Solo 24 Fr Venous Cannula2017-01-26
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
Protek Venous Dilator Set2017-01-26
CARDIACASSIST INC.
Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set2017-01-06
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart Veno-Venous Cannula2016-09-22
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart ProtekDUO Cannula2016-09-22
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart Dual Lumen Cannula2016-09-22
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
THVVC2016-09-22
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
THDLC2016-09-22
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
ProtekDUO2016-09-22
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemLung Oxygenator2016-04-05
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart Wrap2015-10-08
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart Vest2015-10-08
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart Vest - Pump and Oxygenator2015-10-08
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart Vest - Pump Only2015-10-08
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart Pump Holster2015-10-08
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart Veno-Venous Cannula2014-09-25
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart ProtekDUO Cannula2014-09-25
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart Dual Lumen Cannula2014-09-25
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
THVVC2014-09-25
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
THDLC2014-09-25
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
ProtekDUO2014-09-25
CARDIACASSIST INC.
TANDEMHEART VENO-VENOUS CANNULA2014-08-06
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart PROTEK15 Arterial Cannula2014-07-08
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart Arterial Cannula - 15 Fr2014-07-08
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
THAC-152014-07-08
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
PROTEK152014-07-08
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart Venous Cannula2014-07-08
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
THVC2014-07-08
CARDIACASSIST INC.
15 FR. TANDEMHEART ARTERIAL CANNULA2014-02-12
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart?PROTEK17 Arterial Cannula2012-11-05
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart Arterial Cannula2012-11-05
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
THAC2012-11-05
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
PROTEK17 Arterial Cannula2012-11-05
CARDIACASSIST INC.
TANDEMHEART FEMORAL ARTERIAL CANNULA SET2012-05-30
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart System2012-04-02
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart Escort Controller2012-04-02
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart Blood Pump2012-04-02
CARDIACASSIST INC.
TANDEMHEART PUMP2011-09-20
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
Transseptal Cannula Set 72 CM2008-10-09
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart Transseptal Cannula Set 72 CM - Enhanced Flow2008-10-09
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
THTC-EF 722008-10-09
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart XD Controller2007-12-11
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart System Controller2007-12-11
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart Pump2007-12-11
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart Blood Pump2007-12-11
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart System2007-12-11
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart Escort Controller2007-12-11
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart Blood Pump2007-12-11
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart Transseptal Cannula Set2007-12-11
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart Transseptal Cannula Set - Enhanced Flow2007-12-11
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
THTC-EF2007-12-11
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
Transseptal Cannula Set2007-12-11
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
TandemHeart?Transseptal Cannula Set2007-12-11
CARDIAC ASSIST, INC. [CardiacAssist, Inc. dba TandemLife]
THTC2007-12-11

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