FDA 510(k)

CATHTONG III 縮窄型PICC 管針

K 號：K233149 · 2023-12-01

決定日期2023-12-01

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

CATHTONG III Tapered PICC Catheter is the device name listed in this FDA 510(k) record. The listed applicant is L&Z Us, Inc.. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K233149. 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 CATHTONG III Tapered PICC Catheter?

CATHTONG III Tapered PICC Catheter is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is L&Z Us, Inc.. The 510(k) number is K233149.

When did CATHTONG III Tapered PICC Catheter receive FDA 510(k) clearance?

CATHTONG III Tapered PICC Catheter received FDA 510(k) clearance on 2023-12-01, under 510(k) number K233149.

Who is the listed applicant for CATHTONG III Tapered PICC Catheter?

The FDA 510(k) record lists L&Z Us, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CATHTONG III Tapered PICC Catheter?

The FDA product code for CATHTONG III Tapered PICC Catheter is LJS.

其他以 L&Z Us, 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。

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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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官方來源

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