Vascutek, Ltd. 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
Gelweave Vascular Prostheses510(k)Feb 27, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 27, 2025
Gelsoft Plus Vascular Prostheses510(k)Nov 15, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 15, 2024
Vascutek Gelsoft Plus ERS Vascular Graft510(k)Apr 6, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 6, 2021