FDA 510(k)

ProTrack 銅絲尾針

K 號：K213898 · 2023-03-01

決定日期2023-03-01

產品代碼DQX

諮詢委員會履歷

決定相當於

器材摘要

ProTrack Pigtail Wire is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2023-03-01 under 510(k) number K213898. 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 ProTrack Pigtail Wire?

ProTrack Pigtail Wire is a medical device that received FDA 510(k) clearance on 2023-03-01. The listed applicant is Baylis Medical Company, Inc.. The 510(k) number is K213898.

When did ProTrack Pigtail Wire receive FDA 510(k) clearance?

ProTrack Pigtail Wire received FDA 510(k) clearance on 2023-03-01, under 510(k) number K213898.

Who is the listed applicant for ProTrack Pigtail Wire?

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

What is the FDA product code for ProTrack Pigtail Wire?

The FDA product code for ProTrack Pigtail Wire is DQX.

其他以 Baylis Medical Company, Inc. 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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