FDA 510(k)

PowerFlow Apheresis I.V. Port

N.º K: K163001 · 2017-04-17

Fecha de decisión2017-04-17

Código de productoPTD

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

PowerFlow Apheresis I.V. 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 2017-04-17 under 510(k) number K163001. The device is classified under product code PTD. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PowerFlow Apheresis I.V. Port?

PowerFlow Apheresis I.V. Port is a medical device that received FDA 510(k) clearance on 2017-04-17. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K163001.

When did PowerFlow Apheresis I.V. Port receive FDA 510(k) clearance?

PowerFlow Apheresis I.V. Port received FDA 510(k) clearance on 2017-04-17, under 510(k) number K163001.

Who is the listed applicant for PowerFlow Apheresis I.V. 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 Apheresis I.V. Port?

The FDA product code for PowerFlow Apheresis I.V. Port is PTD.

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Fuente oficial

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