FDA 510(k)

FlowArt® ニードルフリー分離セプトムバルブ

K番号: K222889 · 2023-01-20

決定日2023-01-20

製品コードFPA

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

FlowArt® Needle-Free Split Septum Valve is the device name listed in this FDA 510(k) record. The listed applicant is Asset Medikal Tasarim San Tic As.. It received FDA 510(k) clearance on 2023-01-20 under 510(k) number K222889. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the FlowArt® Needle-Free Split Septum Valve?

FlowArt® Needle-Free Split Septum Valve is a medical device that received FDA 510(k) clearance on 2023-01-20. The listed applicant is Asset Medikal Tasarim San Tic As.. The 510(k) number is K222889.

When did FlowArt® Needle-Free Split Septum Valve receive FDA 510(k) clearance?

FlowArt® Needle-Free Split Septum Valve received FDA 510(k) clearance on 2023-01-20, under 510(k) number K222889.

Who is the listed applicant for FlowArt® Needle-Free Split Septum Valve?

The FDA 510(k) record lists Asset Medikal Tasarim San Tic As. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FlowArt® Needle-Free Split Septum Valve?

The FDA product code for FlowArt® Needle-Free Split Septum Valve is FPA.

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FlowArt® ニードルフリー分離セプトムバルブ

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：FPA）

公式ソース