FDA 510(k)

Accoat Guide Wire

Número K: K253667 · 2026-07-14

Data da decisão2026-07-14

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Accoat Guide Wire is the device name listed in this FDA 510(k) record. The listed applicant is Sp Medical A/S. It received FDA 510(k) clearance on 2026-07-14 under 510(k) number K253667. 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 Accoat Guide Wire?

Accoat Guide Wire is a medical device that received FDA 510(k) clearance on 2026-07-14. The listed applicant is Sp Medical A/S. The 510(k) number is K253667.

When did Accoat Guide Wire receive FDA 510(k) clearance?

Accoat Guide Wire received FDA 510(k) clearance on 2026-07-14, under 510(k) number K253667.

Who is the listed applicant for Accoat Guide Wire?

The FDA 510(k) record lists Sp Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Accoat Guide Wire?

The FDA product code for Accoat Guide Wire is DQX.

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Fonte oficial

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