FDA 510(k)

血液透析針管

K 號：K241581 · 2025-05-16

決定日期2025-05-16

產品代碼MSD

諮詢委員會GU

決定Unknown

器材摘要

Hemodialysis Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Haolang Medical USA Corporation. It received FDA 510(k) clearance on 2025-05-16 under 510(k) number K241581. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the Hemodialysis Catheter?

Hemodialysis Catheter is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Haolang Medical USA Corporation. The 510(k) number is K241581.

When did Hemodialysis Catheter receive FDA 510(k) clearance?

Hemodialysis Catheter received FDA 510(k) clearance on 2025-05-16, under 510(k) number K241581.

Who is the listed applicant for Hemodialysis Catheter?

The FDA 510(k) record lists Haolang Medical USA Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hemodialysis Catheter?

The FDA product code for Hemodialysis Catheter is MSD.

其他以 Haolang Medical USA Corporation 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。

K201726動脈針管 K201697胎盤血管導管

相關器械（代碼：MSD）

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。

K210461終端蓋Medical Components Inc (Medcomp)K203575GlidePath 長期血液透析導管C.R. Bard, Inc.K211410GlidePath 13F 長期血液透析針管Bard Peripheral Vascular, Inc.K203767純淨長期血液透析針管C B Bard, Inc.K202150GlidePath 7.5F 長期透析針管C.R. Bard, Inc.K202176Symetrex LTHD 穿刺管，附側孔的 Symetrex LTHD 穿刺管Medical Components, Inc. (dba MedComp)

官方來源

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