FDA 510(k)

卡斯多、阿基里斯和赫米斯NC PTA擴張球囊心导管

K 號：K160941 · 2016-12-13

決定日期2016-12-13

產品代碼LIT

諮詢委員會履歷

決定相當於

器材摘要

Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Brosmed Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-12-13 under 510(k) number K160941. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter?

Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2016-12-13. The listed applicant is Brosmed Medical Co., Ltd.. The 510(k) number is K160941.

When did Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter receive FDA 510(k) clearance?

Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2016-12-13, under 510(k) number K160941.

Who is the listed applicant for Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter?

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

What is the FDA product code for Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter?

The FDA product code for Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter is LIT.

其他以 Brosmed Medical Co., Ltd. 為申請人之記錄

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相關器械（代碼：LIT）

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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