Ablacon, Inc. FDA Approvals

0 new drug approvals and 3 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
Ablamap® System510(k)Jun 8, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 8, 2023
Ablacath Mapping Catheter510(k)Mar 17, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 17, 2023
Ablamap Software510(k)Aug 31, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 31, 2021