FDA 510(k)

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire

Número K: K250552 · 2025-07-25

Data da decisão2025-07-25

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2025-07-25 under 510(k) number K250552. 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 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire?

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire is a medical device that received FDA 510(k) clearance on 2025-07-25. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K250552.

When did Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire receive FDA 510(k) clearance?

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire received FDA 510(k) clearance on 2025-07-25, under 510(k) number K250552.

Who is the listed applicant for Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire?

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

What is the FDA product code for Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire?

The FDA product code for Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire is DQX.

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Fonte oficial

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