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FDA 510(k)

VIOLA

K-Number: K203307 · 2021-02-17

ApplicantVascular Graft Solutions, Ltd.
Decision Date2021-02-17
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VIOLA is a medical device manufactured by Vascular Graft Solutions, Ltd.. It received FDA 510(k) clearance on 2021-02-17 under approval number K203307. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIOLA?

VIOLA is a medical device that received FDA 510(k) clearance on 2021-02-17. It is manufactured by Vascular Graft Solutions, Ltd.. The 510(k) number is K203307.

When was VIOLA approved by the FDA?

VIOLA received FDA 510(k) clearance on 2021-02-17, under approval number K203307.

What company makes VIOLA?

VIOLA is manufactured by Vascular Graft Solutions, Ltd..

What is the FDA product code for VIOLA?

The FDA product code for VIOLA is DXC.

Other Devices by Vascular Graft Solutions, Ltd.

K230248VIOLA

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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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