FDA 510(k)

HI-TORQUE Steelcore Bare Guide Wire

Número K: K200144 · 2020-04-08

Data da decisão2020-04-08

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

HI-TORQUE Steelcore Bare 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 2020-04-08 under 510(k) number K200144. 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 Steelcore Bare Guide Wire?

HI-TORQUE Steelcore Bare Guide Wire is a medical device that received FDA 510(k) clearance on 2020-04-08. The listed applicant is Abbott Vascular. The 510(k) number is K200144.

When did HI-TORQUE Steelcore Bare Guide Wire receive FDA 510(k) clearance?

HI-TORQUE Steelcore Bare Guide Wire received FDA 510(k) clearance on 2020-04-08, under 510(k) number K200144.

Who is the listed applicant for HI-TORQUE Steelcore Bare 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 Steelcore Bare Guide Wire?

The FDA product code for HI-TORQUE Steelcore Bare Guide Wire is DQX.

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Fonte oficial

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