FDA 510(k)

RX Takeru 機器人氣球擴張導管

K 號：K163372 · 2017-04-07

決定日期2017-04-07

產品代碼LOX

諮詢委員會履歷

決定相當於

器材摘要

RX Takeru Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is KANEKA Corporation. It received FDA 510(k) clearance on 2017-04-07 under 510(k) number K163372. 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 RX Takeru Balloon Dilatation Catheter?

RX Takeru Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2017-04-07. The listed applicant is KANEKA Corporation. The 510(k) number is K163372.

When did RX Takeru Balloon Dilatation Catheter receive FDA 510(k) clearance?

RX Takeru Balloon Dilatation Catheter received FDA 510(k) clearance on 2017-04-07, under 510(k) number K163372.

Who is the listed applicant for RX Takeru Balloon Dilatation Catheter?

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

What is the FDA product code for RX Takeru Balloon Dilatation Catheter?

The FDA product code for RX Takeru Balloon Dilatation Catheter is LOX.

其他以 KANEKA Corporation 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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