FineCross M3
K-Number: K203521 · 2021-03-03
Decision Date2021-03-03
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
FineCross M3 is a medical device manufactured by Ashitaka Factory of Terumo Corporation. It received FDA 510(k) clearance on 2021-03-03 under approval number K203521. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FineCross M3?
FineCross M3 is a medical device that received FDA 510(k) clearance on 2021-03-03. It is manufactured by Ashitaka Factory of Terumo Corporation. The 510(k) number is K203521.
When was FineCross M3 approved by the FDA?
FineCross M3 received FDA 510(k) clearance on 2021-03-03, under approval number K203521.
What company makes FineCross M3?
FineCross M3 is manufactured by Ashitaka Factory of Terumo Corporation.
What is the FDA product code for FineCross M3?
The FDA product code for FineCross M3 is DQY.
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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.