FDA 510(k)

聚四氟乙烯導絲

K 號：K242824 · 2024-12-06

決定日期2024-12-06

產品代碼DQX

諮詢委員會履歷

決定相當於

器材摘要

PTFE Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Lake Region Medical. It received FDA 510(k) clearance on 2024-12-06 under 510(k) number K242824. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PTFE Guidewire?

PTFE Guidewire is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is Lake Region Medical. The 510(k) number is K242824.

When did PTFE Guidewire receive FDA 510(k) clearance?

PTFE Guidewire received FDA 510(k) clearance on 2024-12-06, under 510(k) number K242824.

Who is the listed applicant for PTFE Guidewire?

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

What is the FDA product code for PTFE Guidewire?

The FDA product code for PTFE Guidewire is DQX.

其他以 Lake Region Medical 為申請人之記錄

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相關器械（代碼：DQX）

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。

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官方來源

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