FFRangio System
K-Number: K182149 · 2018-12-19
ApplicantCathworks, Ltd.
Decision Date2018-12-19
Product CodeQEK
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
FFRangio System is a medical device manufactured by Cathworks, Ltd.. It received FDA 510(k) clearance on 2018-12-19 under approval number K182149. The device is classified under product code QEK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FFRangio System?
FFRangio System is a medical device that received FDA 510(k) clearance on 2018-12-19. It is manufactured by Cathworks, Ltd.. The 510(k) number is K182149.
When was FFRangio System approved by the FDA?
FFRangio System received FDA 510(k) clearance on 2018-12-19, under approval number K182149.
What company makes FFRangio System?
FFRangio System is manufactured by Cathworks, Ltd..
What is the FDA product code for FFRangio System?
The FDA product code for FFRangio System is QEK.
Other Devices by Cathworks, Ltd.
Related Devices (Code: QEK)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.