Avinger, Inc. FDA Approvals

0 new drug approvals and 4 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
Pantheris LV Atherectomy Catheter510(k)Jun 6, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 6, 2023
Tigereye ST CTO-Crossing Catheter510(k)Apr 25, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 25, 2023
Tigereye CTO-Crossing Catheter510(k)Jan 6, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 6, 2022
Pantheris System510(k)Nov 16, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 16, 2021