FDA 510(k)

SelectFlex 072 Neurovascular Access System

Número K: K191664 · 2019-08-30

Data da decisão2019-08-30

Código do produtoDQY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

SelectFlex 072 Neurovascular Access System is the device name listed in this FDA 510(k) record. The listed applicant is Q'Apel Medical. It received FDA 510(k) clearance on 2019-08-30 under 510(k) number K191664. 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 SelectFlex 072 Neurovascular Access System?

SelectFlex 072 Neurovascular Access System is a medical device that received FDA 510(k) clearance on 2019-08-30. The listed applicant is Q'Apel Medical. The 510(k) number is K191664.

When did SelectFlex 072 Neurovascular Access System receive FDA 510(k) clearance?

SelectFlex 072 Neurovascular Access System received FDA 510(k) clearance on 2019-08-30, under 510(k) number K191664.

Who is the listed applicant for SelectFlex 072 Neurovascular Access System?

The FDA 510(k) record lists Q'Apel Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SelectFlex 072 Neurovascular Access System?

The FDA product code for SelectFlex 072 Neurovascular Access System is DQY.

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