Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Cardiacassist, Inc.

FDA 510(k) & PMA Approved Devices — 18 products

Total Devices18
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K233736 LifeSPARC SystemQNR2024-01-19 View
510(k) K232480 ProtekDuo Veno-Venous Cannula SetsPZS2023-10-06 View
510(k) K232132 LifeSPARC SystemKFM2023-08-03 View
510(k) K211830 LifeSPARC SystemQNR2022-11-15 View
510(k) K202751 TandemHeart Pump and Escort ControllerQNR2021-03-26 View
510(k) K183623 LifeSPARC Pump, LifeSPARC ControllerKFM2019-07-09 View
510(k) K181150 ProtekDuo Mini Veno-Venous Cannula SetDWF2018-05-25 View
510(k) K162181 Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetDRE2017-01-06 View
510(k) K162214 Protek Solo 24 Fr Venous Cannula SetDWF2016-11-30 View
510(k) K160257 PROTEK Duo 31 Fr. Veno-Venous Cannula SetDWF2016-03-04 View
510(k) K153295 TandemLung OxygenatorDTZ2016-02-26 View
510(k) K120543 TANDEMHEART FEMORAL ARTERIAL CANNULA SETDWF2012-05-30 View
510(k) K110493 TANDEMHEART PUMPKFM2011-09-20 View
510(k) K082425 TANDEMHEART TRANSSEPTAL CANNULA- EF 72DWF2008-09-18 View
510(k) K061369 TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500DWA2006-08-22 View
510(k) K052570 TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221DWF2006-01-17 View
510(k) K030398 CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221DQR2003-05-23 View
510(k) K991783 AB-180 XC SYSTEM, MODEL AB-180XCKFM2000-11-01 View
↑