Terumo Cardiovascular Systems Corporation FDA Approvals

0 new drug approvals and 3 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
CDI OneView Monitoring System510(k)Apr 25, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 25, 2024
Terumo Advanced Perfusion System 1510(k)Apr 18, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 18, 2023
Capiox iCP Centrifugal Pump510(k)Nov 18, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 18, 2021