FDA 510(k)

TidalPort-AP Implantable Apheresis Vascular Access Port

N.º K: K192291 · 2020-08-20

SolicitanteNorfolk Medical Products, Inc.

Fecha de decisión2020-08-20

Código de productoPTD

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

TidalPort-AP Implantable Apheresis Vascular Access Port is the device name listed in this FDA 510(k) record. The listed applicant is Norfolk Medical Products, Inc.. It received FDA 510(k) clearance on 2020-08-20 under 510(k) number K192291. 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 TidalPort-AP Implantable Apheresis Vascular Access Port?

TidalPort-AP Implantable Apheresis Vascular Access Port is a medical device that received FDA 510(k) clearance on 2020-08-20. The listed applicant is Norfolk Medical Products, Inc.. The 510(k) number is K192291.

When did TidalPort-AP Implantable Apheresis Vascular Access Port receive FDA 510(k) clearance?

TidalPort-AP Implantable Apheresis Vascular Access Port received FDA 510(k) clearance on 2020-08-20, under 510(k) number K192291.

Who is the listed applicant for TidalPort-AP Implantable Apheresis Vascular Access Port?

The FDA 510(k) record lists Norfolk Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TidalPort-AP Implantable Apheresis Vascular Access Port?

The FDA product code for TidalPort-AP Implantable Apheresis Vascular Access Port is PTD.

Ensayos clínicos relacionados

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Dispositivos relacionados (Código: PTD)

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Fuente oficial

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