FDA 510(k)

KardiFlex PTCA 膨脹球囊擴張針

K 號：K202619 · 2021-04-29

決定日期2021-04-29

產品代碼LOX

諮詢委員會履歷

決定相當於

器材摘要

KardiFlex PTCA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medcaptain Life Science Co., Ltd.. It received FDA 510(k) clearance on 2021-04-29 under 510(k) number K202619. 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 KardiFlex PTCA Balloon Dilatation Catheter?

KardiFlex PTCA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2021-04-29. The listed applicant is Medcaptain Life Science Co., Ltd.. The 510(k) number is K202619.

When did KardiFlex PTCA Balloon Dilatation Catheter receive FDA 510(k) clearance?

KardiFlex PTCA Balloon Dilatation Catheter received FDA 510(k) clearance on 2021-04-29, under 510(k) number K202619.

Who is the listed applicant for KardiFlex PTCA Balloon Dilatation Catheter?

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

What is the FDA product code for KardiFlex PTCA Balloon Dilatation Catheter?

The FDA product code for KardiFlex PTCA Balloon Dilatation Catheter is LOX.

其他以 Medcaptain Life Science 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。

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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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