FDA 510(k)

HI-TORQUE PROCEED Guide Wire Family

Número K: K201834 · 2020-07-30

Data da decisão2020-07-30

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

HI-TORQUE PROCEED 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 2020-07-30 under 510(k) number K201834. 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 PROCEED Guide Wire Family?

HI-TORQUE PROCEED Guide Wire Family is a medical device that received FDA 510(k) clearance on 2020-07-30. The listed applicant is Abbott Vascular. The 510(k) number is K201834.

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

HI-TORQUE PROCEED Guide Wire Family received FDA 510(k) clearance on 2020-07-30, under 510(k) number K201834.

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

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

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Outros registros que listam Abbott Vascular como candidato(a)

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Fonte oficial

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