Cardiacassist, Inc. FDA Approvals

0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
LifeSPARC System510(k)Jan 19, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 19, 2024
ProtekDuo Veno-Venous Cannula Sets510(k)Oct 6, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 6, 2023
LifeSPARC System510(k)Aug 3, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Aug 3, 2023
LifeSPARC System510(k)Nov 15, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 15, 2022
TandemHeart Pump and Escort Controller510(k)Mar 26, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 26, 2021