FDA 510(k)

Hi-Torque Command 18 Guide Wire

Número K: K172073 · 2017-08-25

Data da decisão2017-08-25

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hi-Torque Command 18 Guide Wire is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular. It received FDA 510(k) clearance on 2017-08-25 under 510(k) number K172073. 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 Hi-Torque Command 18 Guide Wire?

Hi-Torque Command 18 Guide Wire is a medical device that received FDA 510(k) clearance on 2017-08-25. The listed applicant is Abbott Vascular. The 510(k) number is K172073.

When did Hi-Torque Command 18 Guide Wire receive FDA 510(k) clearance?

Hi-Torque Command 18 Guide Wire received FDA 510(k) clearance on 2017-08-25, under 510(k) number K172073.

Who is the listed applicant for Hi-Torque Command 18 Guide Wire?

The FDA 510(k) record lists Abbott Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hi-Torque Command 18 Guide Wire?

The FDA product code for Hi-Torque Command 18 Guide Wire is DQX.

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Fonte oficial

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