FDA 510(k)

Route 92 Medical Sheath System

Número K: K191717 · 2020-01-13

Data da decisão2020-01-13

Código do produtoDQY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Route 92 Medical Sheath System is the device name listed in this FDA 510(k) record. The listed applicant is Route 92 Medical, Inc.. It received FDA 510(k) clearance on 2020-01-13 under 510(k) number K191717. 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 Route 92 Medical Sheath System?

Route 92 Medical Sheath System is a medical device that received FDA 510(k) clearance on 2020-01-13. The listed applicant is Route 92 Medical, Inc.. The 510(k) number is K191717.

When did Route 92 Medical Sheath System receive FDA 510(k) clearance?

Route 92 Medical Sheath System received FDA 510(k) clearance on 2020-01-13, under 510(k) number K191717.

Who is the listed applicant for Route 92 Medical Sheath System?

The FDA 510(k) record lists Route 92 Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Route 92 Medical Sheath System?

The FDA product code for Route 92 Medical Sheath System is DQY.

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Fonte oficial

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