FDA 510(k)

SeQure® NF and SeQure® Microcatheters

Número K: K173430 · 2018-01-26

RequerenteAccurate Medical Therapeutics, Ltd.

Data da decisão2018-01-26

Código do produtoDQO

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

SeQure® NF and SeQure® Microcatheters is the device name listed in this FDA 510(k) record. The listed applicant is Accurate Medical Therapeutics, Ltd.. It received FDA 510(k) clearance on 2018-01-26 under 510(k) number K173430. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SeQure® NF and SeQure® Microcatheters?

SeQure® NF and SeQure® Microcatheters is a medical device that received FDA 510(k) clearance on 2018-01-26. The listed applicant is Accurate Medical Therapeutics, Ltd.. The 510(k) number is K173430.

When did SeQure® NF and SeQure® Microcatheters receive FDA 510(k) clearance?

SeQure® NF and SeQure® Microcatheters received FDA 510(k) clearance on 2018-01-26, under 510(k) number K173430.

Who is the listed applicant for SeQure® NF and SeQure® Microcatheters?

The FDA 510(k) record lists Accurate Medical Therapeutics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SeQure® NF and SeQure® Microcatheters?

The FDA product code for SeQure® NF and SeQure® Microcatheters is DQO.

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Fonte oficial

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