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FDA 510(k)

VASSALLO GT 018 Floppy

K-Number: K213949 · 2022-06-30

ApplicantFilmecc Co., Ltd.
Decision Date2022-06-30
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASSALLO GT 018 Floppy is a medical device manufactured by Filmecc Co., Ltd.. It received FDA 510(k) clearance on 2022-06-30 under approval number K213949. 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 Floppy?

VASSALLO GT 018 Floppy is a medical device that received FDA 510(k) clearance on 2022-06-30. It is manufactured by Filmecc Co., Ltd.. The 510(k) number is K213949.

When was VASSALLO GT 018 Floppy approved by the FDA?

VASSALLO GT 018 Floppy received FDA 510(k) clearance on 2022-06-30, under approval number K213949.

What company makes VASSALLO GT 018 Floppy?

VASSALLO GT 018 Floppy is manufactured by Filmecc Co., Ltd..

What is the FDA product code for VASSALLO GT 018 Floppy?

The FDA product code for VASSALLO GT 018 Floppy is DQX.

Other Devices by Filmecc Co., Ltd.

K203529VASSALLO GT Hybrid K203533VASSALLO GT K222631VASSALLO GT EXT K223432Vassallo GT 018 Hybrid

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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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