FDA 510(k)

Venclose 電波系統（digiRF 產生器，EVSRF 穿刺電極）

K 號：K160754 · 2016-09-09

決定日期2016-09-09

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

Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) is the device name listed in this FDA 510(k) record. The listed applicant is Venclose, Inc.. It received FDA 510(k) clearance on 2016-09-09 under 510(k) number K160754. 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 Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)?

Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Venclose, Inc.. The 510(k) number is K160754.

When did Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) receive FDA 510(k) clearance?

Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) received FDA 510(k) clearance on 2016-09-09, under 510(k) number K160754.

Who is the listed applicant for Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)?

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

What is the FDA product code for Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)?

The FDA product code for Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) is GEI.

其他以 Venclose, Inc. 為申請人之記錄

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。

K252316Venclose digiRF 產生器 (VCRFG1)；Venclose EVSRF 穿刺針 (VC10A256F60, VC10A256F100)K250068Venclose數位RF發生器（VCRFG1）K211806Venclose digiRF 產生器搭配 Maven 管腔導管，Venclose Maven 系統，Venclose digiRF 產生器，Venclose Maven 管腔導管

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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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