FDA 510(k)

CATHTONG™ II PICC 穿刺導管

K 號：K232571 · 2023-09-22

決定日期2023-09-22

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™ II 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 2023-09-22 under 510(k) number K232571. 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™ II PICC Catheter?

CATHTONG™ II PICC Catheter is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is L&Z Us, Inc.. The 510(k) number is K232571.

When did CATHTONG™ II PICC Catheter receive FDA 510(k) clearance?

CATHTONG™ II PICC Catheter received FDA 510(k) clearance on 2023-09-22, under 510(k) number K232571.

Who is the listed applicant for CATHTONG™ II 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™ II PICC Catheter?

The FDA product code for CATHTONG™ II 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。

K233149CATHTONG III 縮窄型PICC 管針 K232594CATHTONG™ II PICC 穿刺導管 K172039CATHTONG II PICC 尿管 K170486CATHTONG II PICC 尿管 K153469貓通 I PICC 尿管

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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