FDA 510(k)

セントロベナ・セントラル・ヴェナ・キャテター（CVC）およびセントロベナ・ワン・インサーション・システム

K番号: K242429 · 2025-04-09

決定日2025-04-09

製品コードSEF

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

CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Inc. (Bd). It received FDA 510(k) clearance on 2025-04-09 under 510(k) number K242429. The device is classified under product code SEF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System?

CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System is a medical device that received FDA 510(k) clearance on 2025-04-09. The listed applicant is Becton Dickinson Inc. (Bd). The 510(k) number is K242429.

When did CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System receive FDA 510(k) clearance?

CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System received FDA 510(k) clearance on 2025-04-09, under 510(k) number K242429.

Who is the listed applicant for CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System?

The FDA 510(k) record lists Becton Dickinson Inc. (Bd) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System?

The FDA product code for CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System is SEF.

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医療機器の概要

よくある質問

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