FDA 510(k)

HI-TORQUE InfilTrac Guide Wire Family

Número K: K193126 · 2019-12-11

Data da decisão2019-12-11

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

HI-TORQUE InfilTrac 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 2019-12-11 under 510(k) number K193126. 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 InfilTrac Guide Wire Family?

HI-TORQUE InfilTrac Guide Wire Family is a medical device that received FDA 510(k) clearance on 2019-12-11. The listed applicant is Abbott Vascular. The 510(k) number is K193126.

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

HI-TORQUE InfilTrac Guide Wire Family received FDA 510(k) clearance on 2019-12-11, under 510(k) number K193126.

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

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

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Fonte oficial

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