FDA 510(k)

火飛針無針連接器

K 號：K203796 · 2021-07-30

決定日期2021-07-30

產品代碼FPA

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

Firefly Needleless Connector is the device name listed in this FDA 510(k) record. The listed applicant is Puracath Medical, Inc.. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K203796. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Firefly Needleless Connector?

Firefly Needleless Connector is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Puracath Medical, Inc.. The 510(k) number is K203796.

When did Firefly Needleless Connector receive FDA 510(k) clearance?

Firefly Needleless Connector received FDA 510(k) clearance on 2021-07-30, under 510(k) number K203796.

Who is the listed applicant for Firefly Needleless Connector?

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

What is the FDA product code for Firefly Needleless Connector?

The FDA product code for Firefly Needleless Connector is FPA.

其他以 Puracath Medical, Inc. 為申請人之記錄

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。

K251375PuraCath 火飛無針連接器 IT (9005)K151620火飛蟬腹膜透析連接器消毒系統

相關器械（代碼：FPA）

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。

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官方來源

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