FDA 510(k)

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

N.º K: K211223 · 2021-07-21

SolicitanteBoston Scientific Corporation

Fecha de decisión2021-07-21

Código de productoOTN

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del 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 2021-07-21 under 510(k) number K211223. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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 2021-07-21. The listed applicant is Boston Scientific Corporation. The 510(k) number is K211223.

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 2021-07-21, under 510(k) number K211223.

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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Fuente oficial

Ver en la base de datos de la FDA →

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