Suzhou Zenith Vascular SciTech Limited 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
Zenith Distal Access Long Sheath510(k)May 22, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 22, 2026
Zenith Aspiration Catheter; Disposable Aspiration Tubing Set510(k)May 20, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 20, 2026
Zenith Micro Guidewire510(k)Apr 16, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 16, 2026
Micro Catheter510(k)Jul 30, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 30, 2025