Route 92 Medical, Inc. FDA Approvals

0 new drug approvals and 8 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
Route 92 Medical Full Length 046 Access System510(k)Sep 16, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 16, 2026
Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set510(k)May 19, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 19, 2025
8F Modified Sheath System510(k)Oct 2, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Oct 2, 2024
Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set510(k)Apr 23, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Apr 23, 2024
Route 92 Medical Full Length 054 Access System510(k)Aug 15, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Aug 15, 2023
Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set510(k)Apr 11, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 11, 2023
Route 92 Medical Full Length 070 Access System510(k)Oct 4, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Oct 4, 2022
Route 92 Medical Full Length 088 Access System510(k)Jul 27, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Jul 27, 2021