SmartWise Sweden AB 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
Extroducer Infusion Catheter System510(k)Sep 11, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 11, 2026
Extroducer Infusion Catheter System510(k)Jun 10, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 10, 2022