VASSALLO GT 018 G12; VASSALLO GT 018 G30
K-Number: K232578 · 2023-10-11
ApplicantFilmec Co. , Ltd.
Decision Date2023-10-11
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
VASSALLO GT 018 G12; VASSALLO GT 018 G30 is a medical device manufactured by Filmec Co. , Ltd.. It received FDA 510(k) clearance on 2023-10-11 under approval number K232578. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VASSALLO GT 018 G12; VASSALLO GT 018 G30?
VASSALLO GT 018 G12; VASSALLO GT 018 G30 is a medical device that received FDA 510(k) clearance on 2023-10-11. It is manufactured by Filmec Co. , Ltd.. The 510(k) number is K232578.
When was VASSALLO GT 018 G12; VASSALLO GT 018 G30 approved by the FDA?
VASSALLO GT 018 G12; VASSALLO GT 018 G30 received FDA 510(k) clearance on 2023-10-11, under approval number K232578.
What company makes VASSALLO GT 018 G12; VASSALLO GT 018 G30?
VASSALLO GT 018 G12; VASSALLO GT 018 G30 is manufactured by Filmec Co. , Ltd..
What is the FDA product code for VASSALLO GT 018 G12; VASSALLO GT 018 G30?
The FDA product code for VASSALLO GT 018 G12; VASSALLO GT 018 G30 is DQX.
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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.