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FDA 510(k)

VASSALLO GT Crossing14

K-Number: K232574 · 2023-10-11

ApplicantFilmec Co. , Ltd.
Decision Date2023-10-11
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASSALLO GT Crossing14 is a medical device manufactured by Filmec Co. , Ltd.. It received FDA 510(k) clearance on 2023-10-11 under approval number K232574. 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 Crossing14?

VASSALLO GT Crossing14 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 K232574.

When was VASSALLO GT Crossing14 approved by the FDA?

VASSALLO GT Crossing14 received FDA 510(k) clearance on 2023-10-11, under approval number K232574.

What company makes VASSALLO GT Crossing14?

VASSALLO GT Crossing14 is manufactured by Filmec Co. , Ltd..

What is the FDA product code for VASSALLO GT Crossing14?

The FDA product code for VASSALLO GT Crossing14 is DQX.

Other Devices by Filmec Co. , Ltd.

K232578VASSALLO GT 018 G12; VASSALLO GT 018 G30

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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.

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