FDA 510(k)

ULTRASCORE 集中力量PTA 機器球

K 號：K172571 · 2017-09-22

決定日期2017-09-22

產品代碼PNO

諮詢委員會履歷

決定相當於

器材摘要

ULTRASCORE Focused Force PTA Balloon is the device name listed in this FDA 510(k) record. The listed applicant is C. R. Bard. It received FDA 510(k) clearance on 2017-09-22 under 510(k) number K172571. 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 ULTRASCORE Focused Force PTA Balloon?

ULTRASCORE Focused Force PTA Balloon is a medical device that received FDA 510(k) clearance on 2017-09-22. The listed applicant is C. R. Bard. The 510(k) number is K172571.

When did ULTRASCORE Focused Force PTA Balloon receive FDA 510(k) clearance?

ULTRASCORE Focused Force PTA Balloon received FDA 510(k) clearance on 2017-09-22, under 510(k) number K172571.

Who is the listed applicant for ULTRASCORE Focused Force PTA Balloon?

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

What is the FDA product code for ULTRASCORE Focused Force PTA Balloon?

The FDA product code for ULTRASCORE Focused Force PTA Balloon is PNO.

其他以 C. R. Bard 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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