FDA 510(k)

Mechanical Guidewire

Número K: K221351 · 2022-12-19

Data da decisão2022-12-19

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Mechanical Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2022-12-19 under 510(k) number K221351. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Mechanical Guidewire?

Mechanical Guidewire is a medical device that received FDA 510(k) clearance on 2022-12-19. The listed applicant is Baylis Medical Company, Inc.. The 510(k) number is K221351.

When did Mechanical Guidewire receive FDA 510(k) clearance?

Mechanical Guidewire received FDA 510(k) clearance on 2022-12-19, under 510(k) number K221351.

Who is the listed applicant for Mechanical Guidewire?

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

What is the FDA product code for Mechanical Guidewire?

The FDA product code for Mechanical Guidewire is DQX.

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Fonte oficial

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