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Cardiac Assist, Inc

4 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray recall (Z-2465-2023)Cardiac Assist, Inc2023-08-25
SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLL recall (Z-0926-2023)Cardiac Assist, Inc2023-01-19
TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Con recall (Z-1763-2022)Cardiac Assist, Inc2022-09-23
TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly The TandemHeart Trans recall (Z-0889-2011)Cardiac Assist, Inc2011-01-10

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Every clearance here is in the API, with alerts when new ones post.