FDA 510(k)

Vein360 静脈內放射頻率消融 (RFA) 穿刺針

K 號：K191073 · 2019-10-22

決定日期2019-10-22

產品代碼NUJ

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

Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Vein 360, LLC. It received FDA 510(k) clearance on 2019-10-22 under 510(k) number K191073. The device is classified under product code NUJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter?

Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter is a medical device that received FDA 510(k) clearance on 2019-10-22. The listed applicant is Vein 360, LLC. The 510(k) number is K191073.

When did Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter receive FDA 510(k) clearance?

Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter received FDA 510(k) clearance on 2019-10-22, under 510(k) number K191073.

Who is the listed applicant for Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter?

The FDA 510(k) record lists Vein 360, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter?

The FDA product code for Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter is NUJ.

其他以 Vein 360, LLC 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。

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相關器械（代碼：NUJ）

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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