FDA 510(k)

VIA 17 Microcatheter

Número K: K162565 · 2017-02-18

Data da decisão2017-02-18

Código do produtoDQY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

VIA 17 Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Sequent Medical, Inc.. It received FDA 510(k) clearance on 2017-02-18 under 510(k) number K162565. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VIA 17 Microcatheter?

VIA 17 Microcatheter is a medical device that received FDA 510(k) clearance on 2017-02-18. The listed applicant is Sequent Medical, Inc.. The 510(k) number is K162565.

When did VIA 17 Microcatheter receive FDA 510(k) clearance?

VIA 17 Microcatheter received FDA 510(k) clearance on 2017-02-18, under 510(k) number K162565.

Who is the listed applicant for VIA 17 Microcatheter?

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

What is the FDA product code for VIA 17 Microcatheter?

The FDA product code for VIA 17 Microcatheter is DQY.

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