FDA 510(k)

Serranator Alto PTA 齒輪氣囊心导管

K 號：K163380 · 2017-02-13

決定日期2017-02-13

產品代碼PNO

諮詢委員會履歷

決定相當於

器材摘要

Serranator Alto PTA Serration Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cagent Vascular, LLC. It received FDA 510(k) clearance on 2017-02-13 under 510(k) number K163380. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Serranator Alto PTA Serration Balloon Catheter?

Serranator Alto PTA Serration Balloon Catheter is a medical device that received FDA 510(k) clearance on 2017-02-13. The listed applicant is Cagent Vascular, LLC. The 510(k) number is K163380.

When did Serranator Alto PTA Serration Balloon Catheter receive FDA 510(k) clearance?

Serranator Alto PTA Serration Balloon Catheter received FDA 510(k) clearance on 2017-02-13, under 510(k) number K163380.

Who is the listed applicant for Serranator Alto PTA Serration Balloon Catheter?

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

What is the FDA product code for Serranator Alto PTA Serration Balloon Catheter?

The FDA product code for Serranator Alto PTA Serration Balloon Catheter is PNO.

其他以 Cagent Vascular, 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：PNO）

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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