Suzhou Hengrui Hongyuan Medical 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
Micro Catheter and Guidewire System510(k)Apr 11, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 11, 2022
HRSpheres Narrow-Size Embolic Microspheres510(k)Oct 1, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 1, 2021