Home / Companies / Cardiacassist, Inc.

Cardiacassist, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
21
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K233736LifeSPARC SystemJanuary 19, 2024
K232480ProtekDuo Veno-Venous Cannula SetsOctober 6, 2023
K232132LifeSPARC SystemAugust 3, 2023
K211830LifeSPARC SystemNovember 15, 2022
K202751TandemHeart Pump and Escort ControllerMarch 26, 2021
K183623LifeSPARC Pump, LifeSPARC ControllerJuly 9, 2019
K181150ProtekDuo Mini Veno-Venous Cannula SetMay 25, 2018
K162181Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetJanuary 6, 2017
K162214Protek Solo 24 Fr Venous Cannula SetNovember 30, 2016
K160257PROTEK Duo 31 Fr. Veno-Venous Cannula SetMarch 4, 2016
K153295TandemLung OxygenatorFebruary 26, 2016
K140999TANDEMHEART VENO-VENOUS CANNULAAugust 6, 2014
K13329315 FR. TANDEMHEART ARTERIAL CANNULAFebruary 12, 2014
K133236TANDEMHEART FEMORAL VENOUS CANNULA SETJanuary 29, 2014
K120543TANDEMHEART FEMORAL ARTERIAL CANNULA SETMay 30, 2012
K110493TANDEMHEART PUMPSeptember 20, 2011
K082425TANDEMHEART TRANSSEPTAL CANNULA- EF 72September 18, 2008
K061369TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500August 22, 2006
K052570TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221January 17, 2006
K030398CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221May 23, 2003