FDA 510(k)

ScleroSafe™ 150 mm, ScleroSafe™ 350 mm

Número K: K231148 · 2023-06-20

Data da decisão2023-06-20

Código do produtoKRA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

ScleroSafe™ 150 mm, ScleroSafe™ 350 mm is the device name listed in this FDA 510(k) record. The listed applicant is Vvt Medical , Ltd.. It received FDA 510(k) clearance on 2023-06-20 under 510(k) number K231148. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Vvt Medical , Ltd.. The 510(k) number is K231148.

When did ScleroSafe™ 150 mm, ScleroSafe™ 350 mm receive FDA 510(k) clearance?

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

Who is the listed applicant for ScleroSafe™ 150 mm, ScleroSafe™ 350 mm?

The FDA 510(k) record lists Vvt Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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