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Cardiacassist, Inc.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories6
Latest FDA decision2024-01-19
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
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