Wallaby Medical FDA Approvals

0 new drug approvals and 6 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
p17 XR Microcatheter510(k)Aug 18, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 18, 2026
Esperance 3+ Aspiration Catheter System510(k)Oct 1, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 1, 2024
Esperance Distal Access Catheter510(k)Mar 8, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 8, 2024
Paragon 8F Balloon Guide Catheter510(k)Oct 13, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 13, 2023
Wallaby 017 Micro Catheter510(k)Apr 25, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 25, 2023
Esperance Aspiration Catheter System510(k)Nov 16, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 16, 2021