FDA 510(k)

ScleroSafe 150 mm, ScleroSafe 350 mm

K-Number: K231148 · 2023-06-20

Decision Date2023-06-20

Product CodeKRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ScleroSafe 150 mm, ScleroSafe 350 mm is a medical device manufactured by Vvt Medical , Ltd.. It received FDA 510(k) clearance on 2023-06-20 under approval number K231148. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ScleroSafe 150 mm, ScleroSafe 350 mm?

ScleroSafe 150 mm, ScleroSafe 350 mm is a medical device that received FDA 510(k) clearance on 2023-06-20. It is manufactured by Vvt Medical , Ltd.. The 510(k) number is K231148.

When was ScleroSafe 150 mm, ScleroSafe 350 mm approved by the FDA?

ScleroSafe 150 mm, ScleroSafe 350 mm received FDA 510(k) clearance on 2023-06-20, under approval number K231148.

What company makes ScleroSafe 150 mm, ScleroSafe 350 mm?

ScleroSafe 150 mm, ScleroSafe 350 mm is manufactured by Vvt Medical , Ltd..

What is the FDA product code for ScleroSafe 150 mm, ScleroSafe 350 mm?

The FDA product code for ScleroSafe 150 mm, ScleroSafe 350 mm is KRA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.