FDA 510(k)

Selethru™ NC PTCA 膨脹球擴張針管

K 號：K211393 · 2021-07-02

決定日期2021-07-02

產品代碼LOX

諮詢委員會履歷

決定相當於

器材摘要

Selethru(TM) NC PTCA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Kossel Medtech (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-07-02 under 510(k) number K211393. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Selethru(TM) NC PTCA Balloon Dilatation Catheter?

Selethru(TM) NC PTCA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2021-07-02. The listed applicant is Kossel Medtech (Suzhou) Co., Ltd.. The 510(k) number is K211393.

When did Selethru(TM) NC PTCA Balloon Dilatation Catheter receive FDA 510(k) clearance?

Selethru(TM) NC PTCA Balloon Dilatation Catheter received FDA 510(k) clearance on 2021-07-02, under 510(k) number K211393.

Who is the listed applicant for Selethru(TM) NC PTCA Balloon Dilatation Catheter?

FDA 510(k) 記錄將科斯爾醫療技術（蘇州）有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Selethru(TM) NC PTCA Balloon Dilatation Catheter?

The FDA product code for Selethru(TM) NC PTCA Balloon Dilatation Catheter is LOX.

其他以 Kossel Medtech (Suzhou) Co., Ltd. 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。

K254212NC PTA 機械擴張導管 K231402HP PTA 擴張球囊心导管 K221245PTA 機器擴張針管 K211349Selebrek PTCA 擴張球囊心导管 K182699Selethru PTCA 擴張球囊心导管

相關器械（代碼：LOX）

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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