FDA 510(k)

PowerFlow Implantable Apheresis IV Port

Número K: K191143 · 2019-08-02

Data da decisão2019-08-02

Código do produtoPTD

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

PowerFlow Implantable Apheresis IV Port is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2019-08-02 under 510(k) number K191143. The device is classified under product code PTD. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PowerFlow Implantable Apheresis IV Port?

PowerFlow Implantable Apheresis IV Port is a medical device that received FDA 510(k) clearance on 2019-08-02. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K191143.

When did PowerFlow Implantable Apheresis IV Port receive FDA 510(k) clearance?

PowerFlow Implantable Apheresis IV Port received FDA 510(k) clearance on 2019-08-02, under 510(k) number K191143.

Who is the listed applicant for PowerFlow Implantable Apheresis IV Port?

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

What is the FDA product code for PowerFlow Implantable Apheresis IV Port?

The FDA product code for PowerFlow Implantable Apheresis IV Port is PTD.

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Dispositivos Relacionados (Código: PTD)

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Fonte oficial

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