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FDA 510(k)

Cedar™ 静脈內射頻電極导管 (ERA-C70-US)；Cedar™ 静脈內射頻電極导管 (ERA-C30-US)；靜脈內射頻發生器 (ERA-G5-US)

K 號：K250688 · 2025-10-07

申請人Acotec Scientific Co., Ltd.
決定日期2025-10-07
產品代碼GEI
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) is the device name listed in this FDA 510(k) record. The listed applicant is Acotec Scientific Co., Ltd.. It received FDA 510(k) clearance on 2025-10-07 under 510(k) number K250688. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)?

Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) is a medical device that received FDA 510(k) clearance on 2025-10-07. The listed applicant is Acotec Scientific Co., Ltd.. The 510(k) number is K250688.

When did Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) receive FDA 510(k) clearance?

Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) received FDA 510(k) clearance on 2025-10-07, under 510(k) number K250688.

Who is the listed applicant for Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)?

The FDA 510(k) record lists Acotec Scientific Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)?

The FDA product code for Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) is GEI.

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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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