Cardiocycle Medical(Suzhou) Co., Ltd. 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
Introducer Sheath Set510(k)Apr 23, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 23, 2026
Introducer Sheath Set510(k)Oct 21, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 21, 2025