FDA 510(k)

Actreen Mini Cateteres Intermittentes Urinários

Número K: K151772 · 2016-02-09

Data da decisão2016-02-09

Código do produtoGBM

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Actreen Mini Intermittent Urinary Catheters is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2016-02-09 under 510(k) number K151772. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Actreen Mini Intermittent Urinary Catheters?

Actreen Mini Intermittent Urinary Catheters is a medical device that received FDA 510(k) clearance on 2016-02-09. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K151772.

When did Actreen Mini Intermittent Urinary Catheters receive FDA 510(k) clearance?

Actreen Mini Intermittent Urinary Catheters received FDA 510(k) clearance on 2016-02-09, under 510(k) number K151772.

Who is the listed applicant for Actreen Mini Intermittent Urinary Catheters?

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

What is the FDA product code for Actreen Mini Intermittent Urinary Catheters?

The FDA product code for Actreen Mini Intermittent Urinary Catheters is GBM.

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Fonte oficial

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