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FDA 510(k)

Dispositivo de Entrega Advantage/Advantage Fit, Dispositivo de Entrega Lynx, Dispositivo de Entrega Obtryx (Curvo & Halo), Dispositivo de Entrega Obtryx II (Curvo & Halo), Dispositivo de Entrega Solyx SIS

Número K: K172565 · 2017-12-20

RequerenteBoston Scientific Corporation
Data da decisão2017-12-20
Código do produtoPWJ
Comité consultivoOB
DecisãoSubstantially Equivalent

Resumo do dispositivo

Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device 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 2017-12-20 under 510(k) number K172565. The device is classified under product code PWJ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device?

Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device is a medical device that received FDA 510(k) clearance on 2017-12-20. The listed applicant is Boston Scientific Corporation. The 510(k) number is K172565.

When did Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device receive FDA 510(k) clearance?

Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device received FDA 510(k) clearance on 2017-12-20, under 510(k) number K172565.

Who is the listed applicant for Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device?

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/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device?

The FDA product code for Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device is PWJ.

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Fonte oficial

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