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FDA 510(k)

VASSALLO GT Hybrid

K-Number: K203529 · 2021-05-04

ApplicantFilmecc Co., Ltd.
Decision Date2021-05-04
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASSALLO GT Hybrid is a medical device manufactured by Filmecc Co., Ltd.. It received FDA 510(k) clearance on 2021-05-04 under approval number K203529. 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 Hybrid?

VASSALLO GT Hybrid is a medical device that received FDA 510(k) clearance on 2021-05-04. It is manufactured by Filmecc Co., Ltd.. The 510(k) number is K203529.

When was VASSALLO GT Hybrid approved by the FDA?

VASSALLO GT Hybrid received FDA 510(k) clearance on 2021-05-04, under approval number K203529.

What company makes VASSALLO GT Hybrid?

VASSALLO GT Hybrid is manufactured by Filmecc Co., Ltd..

What is the FDA product code for VASSALLO GT Hybrid?

The FDA product code for VASSALLO GT Hybrid is DQX.

Other Devices by Filmecc Co., Ltd.

K203533VASSALLO GT K222631VASSALLO GT EXT K213949VASSALLO GT 018 Floppy 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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