FDA 510(k)

93 NeuFlex 緝子

K 號：K251044 · 2025-05-23

決定日期2025-05-23

產品代碼QJP

諮詢委員會履歷

決定相當於

器材摘要

93 NeuFlex Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Piraeus Medical. It received FDA 510(k) clearance on 2025-05-23 under 510(k) number K251044. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 93 NeuFlex Catheter?

93 NeuFlex Catheter is a medical device that received FDA 510(k) clearance on 2025-05-23. The listed applicant is Piraeus Medical. The 510(k) number is K251044.

When did 93 NeuFlex Catheter receive FDA 510(k) clearance?

93 NeuFlex Catheter received FDA 510(k) clearance on 2025-05-23, under 510(k) number K251044.

Who is the listed applicant for 93 NeuFlex Catheter?

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

What is the FDA product code for 93 NeuFlex Catheter?

The FDA product code for 93 NeuFlex Catheter is QJP.

其他以 Piraeus Medical 為申請人之記錄

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K24097187 NeuGlide 緝子

相關器械（代碼：QJP）

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。

K260220路92醫療全長046進入系統Route 92 Medical, Inc.K26227770 神經導引針管Piraeus Medical, Inc.K261176Zoom 4S 管針Imperative Care, Inc.K254071p17 XR 微导管Wallaby Medical K260199SLIM 微导管Balt USA, LLC K253901蟻蟻88 接通導管Perfuze, Ltd.

官方來源

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