FDA 510(k)

HI-TORQUE TurnTrac Guide Wire Family

Número K: K173795 · 2018-01-12

Data da decisão2018-01-12

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

HI-TORQUE TurnTrac Guide Wire Family is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular. It received FDA 510(k) clearance on 2018-01-12 under 510(k) number K173795. 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 TurnTrac Guide Wire Family?

HI-TORQUE TurnTrac Guide Wire Family is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is Abbott Vascular. The 510(k) number is K173795.

When did HI-TORQUE TurnTrac Guide Wire Family receive FDA 510(k) clearance?

HI-TORQUE TurnTrac Guide Wire Family received FDA 510(k) clearance on 2018-01-12, under 510(k) number K173795.

Who is the listed applicant for HI-TORQUE TurnTrac Guide Wire Family?

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 TurnTrac Guide Wire Family?

The FDA product code for HI-TORQUE TurnTrac Guide Wire Family is DQX.

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Fonte oficial

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