Endovascular Engineering 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
Helo Max Thrombectomy System (HEL2090)510(k)Sep 3, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 3, 2026
Cobra Catheter System510(k)Feb 15, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 15, 2023