FDA 510(k)

5 FR雙腔道皮克PICC

K 號：K181904 · 2018-09-25

決定日期2018-09-25

產品代碼LJS

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

5 FR Dual Lumen Piper PICC is the device name listed in this FDA 510(k) record. The listed applicant is Piper Access, LLC. It received FDA 510(k) clearance on 2018-09-25 under 510(k) number K181904. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 5 FR Dual Lumen Piper PICC?

5 FR Dual Lumen Piper PICC is a medical device that received FDA 510(k) clearance on 2018-09-25. The listed applicant is Piper Access, LLC. The 510(k) number is K181904.

When did 5 FR Dual Lumen Piper PICC receive FDA 510(k) clearance?

5 FR Dual Lumen Piper PICC received FDA 510(k) clearance on 2018-09-25, under 510(k) number K181904.

Who is the listed applicant for 5 FR Dual Lumen Piper PICC?

The FDA 510(k) record lists Piper Access, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 5 FR Dual Lumen Piper PICC?

The FDA product code for 5 FR Dual Lumen Piper PICC is LJS.

其他以 Piper Access, LLC 為申請人之記錄

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K210047斯提萊托延長停留式心臟导管 K191976Piper GO-IO 骨內輸液系統

相關器械（代碼：LJS）

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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