FDA 510(k)

Miethke Shunt System GAV 2.0 and SA 2.0 Valves

Número K: K190174 · 2019-07-05

Data da decisão2019-07-05

Código do produtoJXG

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Miethke Shunt System GAV 2.0 and SA 2.0 Valves is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2019-07-05 under 510(k) number K190174. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Miethke Shunt System GAV 2.0 and SA 2.0 Valves?

Miethke Shunt System GAV 2.0 and SA 2.0 Valves is a medical device that received FDA 510(k) clearance on 2019-07-05. The listed applicant is Aesculap, Inc.. The 510(k) number is K190174.

When did Miethke Shunt System GAV 2.0 and SA 2.0 Valves receive FDA 510(k) clearance?

Miethke Shunt System GAV 2.0 and SA 2.0 Valves received FDA 510(k) clearance on 2019-07-05, under 510(k) number K190174.

Who is the listed applicant for Miethke Shunt System GAV 2.0 and SA 2.0 Valves?

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

What is the FDA product code for Miethke Shunt System GAV 2.0 and SA 2.0 Valves?

The FDA product code for Miethke Shunt System GAV 2.0 and SA 2.0 Valves is JXG.

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Fonte oficial

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