FDA 510(k)

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

Número K: K231549 · 2023-06-29

Data da decisão2023-06-29

Código do produtoOTN

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2023-06-29 under 510(k) number K231549. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System?

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System is a medical device that received FDA 510(k) clearance on 2023-06-29. The listed applicant is Boston Scientific Corporation. The 510(k) number is K231549.

When did Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System receive FDA 510(k) clearance?

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System received FDA 510(k) clearance on 2023-06-29, under 510(k) number K231549.

Who is the listed applicant for Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System?

The FDA product code for Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System is OTN.

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Fonte oficial

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