Mivi Neuroscience, Inc. FDA Approvals

0 new drug approvals and 2 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
Q Distal Access Catheter510(k)Sep 19, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 19, 2023
MIVI Q Distal Access Catheter510(k)Dec 16, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Dec 16, 2021