FDA 510(k)

透析カテーテル

K番号: K241581 · 2025-05-16

決定日2025-05-16

製品コードMSD

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定Unknown

医療機器の概要

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.

よくある質問

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.

申請者としてHaolang Medical USA Corporationを記載するその他の記録

K201726動脈カテーテル K201697Umbilical Vessels Catheter

公式ソース

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