FDA 510(k)

TidalPort-AP Implantable Apheresis Vascular Access Port

K-번호: K192291 · 2020-08-20

결정일2020-08-20

제품 코드PTD

자문 위원회의료장비 규제 텍스트 번역 HO [원문 텍스트가 제공되지 않았기 때문에 번역할 수 없습니다. 원문 텍스트를 제공해 주시면 번역을 도와드리겠습니다.]

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

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TidalPort-AP Implantable Apheresis Vascular Access Port

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: PTD)

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