FDA 510(k)

Wellead® Latex Foley Catheter

K番号: K233094 · 2024-06-06

決定日2024-06-06

製品コードMJC

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

決定大幅同等

医療機器の概要

Wellead® Latex Foley Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical (Hainan) Co., Ltd.. It received FDA 510(k) clearance on 2024-06-06 under 510(k) number K233094. The device is classified under product code MJC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Wellead® Latex Foley Catheter?

Wellead® Latex Foley Catheter is a medical device that received FDA 510(k) clearance on 2024-06-06. The listed applicant is Well Lead Medical (Hainan) Co., Ltd.. The 510(k) number is K233094.

When did Wellead® Latex Foley Catheter receive FDA 510(k) clearance?

Wellead® Latex Foley Catheter received FDA 510(k) clearance on 2024-06-06, under 510(k) number K233094.

Who is the listed applicant for Wellead® Latex Foley Catheter?

The FDA 510(k) record lists Well Lead Medical (Hainan) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wellead® Latex Foley Catheter?

The FDA product code for Wellead® Latex Foley Catheter is MJC.

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