FDA 510(k)

潮汐港-AP 埋植式血液濾過血管通路港

K 號：K192291 · 2020-08-20

決定日期2020-08-20

產品代碼PTD

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：PTD）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K191143PowerFlow 埋植式血液濾過系統靜脈插管C.R. Bard, Inc.K163001PowerFlow 分離治療靜脈插管C.R. Bard, Inc.

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：PTD）

官方來源