RADIFOCUS Torque Device
K-Number: K220934 · 2022-06-29
Decision Date2022-06-29
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
RADIFOCUS Torque Device is a medical device manufactured by Terumo Medical Products (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2022-06-29 under approval number K220934. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the RADIFOCUS Torque Device?
RADIFOCUS Torque Device is a medical device that received FDA 510(k) clearance on 2022-06-29. It is manufactured by Terumo Medical Products (Hangzhou) Co., Ltd.. The 510(k) number is K220934.
When was RADIFOCUS Torque Device approved by the FDA?
RADIFOCUS Torque Device received FDA 510(k) clearance on 2022-06-29, under approval number K220934.
What company makes RADIFOCUS Torque Device?
RADIFOCUS Torque Device is manufactured by Terumo Medical Products (Hangzhou) Co., Ltd..
What is the FDA product code for RADIFOCUS Torque Device?
The FDA product code for RADIFOCUS Torque Device is MOF.
Related Clinical Trials
Other Devices by Terumo Medical Products (Hangzhou) Co., Ltd.
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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.