FDA 510(k)

Crosstella RX 機器擴張導管

K 號：K152873 · 2016-01-22

決定日期2016-01-22

產品代碼LIT

諮詢委員會履歷

決定相當於

器材摘要

Crosstella RX 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 2016-01-22 under 510(k) number K152873. 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 Crosstella RX Balloon Dilatation Catheter?

Crosstella RX Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is KANEKA Corporation. The 510(k) number is K152873.

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

Crosstella RX Balloon Dilatation Catheter received FDA 510(k) clearance on 2016-01-22, under 510(k) number K152873.

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

The FDA product code for Crosstella RX Balloon Dilatation Catheter is LIT.

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：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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官方來源

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