Vesalio, Inc. FDA Approvals

0 new drug approvals and 5 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
pVasc Net Mechanical Thrombectomy Device510(k)Aug 5, 2026	—	510(k)Substantially Equivalent (Special)	Aug 5, 2026
V-DAC Catheter510(k)Jan 6, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 6, 2026
NeVa PV Thrombectomy Device510(k)Nov 24, 2025Cardiovascular	Cardiovascular	510(k)Unknown (Traditional)	Nov 24, 2025
NeVasc Aspiration System510(k)Nov 10, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 10, 2025
Vesalio Peripheral System510(k)Oct 24, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 24, 2025