Cardio Flow Inc., FDA Approvals

0 new drug approvals and 5 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
FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)510(k)Apr 25, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Apr 25, 2025
FreedomFlow Orbital Circumferential Atherectomy System510(k)Nov 5, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Nov 5, 2024
FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)510(k)Feb 15, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Feb 15, 2024
FreedomFlow Orbital Circumferential Atherectomy System510(k)Sep 27, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 27, 2023
Cardio Flow Peripheral Guide Wire510(k)Mar 18, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 18, 2022