FDA 510(k)

簡易導引

K 號：K261242 · 2026-06-25

決定日期2026-06-25

產品代碼DYB

諮詢委員會履歷

決定相當於

器材摘要

SimplGuide is the device name listed in this FDA 510(k) record. The listed applicant is Pendracare. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K261242. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SimplGuide?

SimplGuide is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is Pendracare. The 510(k) number is K261242.

When did SimplGuide receive FDA 510(k) clearance?

SimplGuide received FDA 510(k) clearance on 2026-06-25, under 510(k) number K261242.

Who is the listed applicant for SimplGuide?

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

What is the FDA product code for SimplGuide?

The FDA product code for SimplGuide is DYB.

其他以 Pendracare 為申請人之記錄

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K250972首要親水性導引針管

相關器械（代碼：DYB）

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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