FFRangio
K-Number: K192442 · 2019-12-09
ApplicantCathworks, Ltd.
Decision Date2019-12-09
Product CodeQEK
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
FFRangio is a medical device manufactured by Cathworks, Ltd.. It received FDA 510(k) clearance on 2019-12-09 under approval number K192442. 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?
FFRangio is a medical device that received FDA 510(k) clearance on 2019-12-09. It is manufactured by Cathworks, Ltd.. The 510(k) number is K192442.
When was FFRangio approved by the FDA?
FFRangio received FDA 510(k) clearance on 2019-12-09, under approval number K192442.
What company makes FFRangio?
FFRangio is manufactured by Cathworks, Ltd..
What is the FDA product code for FFRangio?
The FDA product code for FFRangio 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.