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FDA 510(k)

CrossCath Support Catheter

K 號:K161801 · 2016-07-29

決定日期2016-07-29
產品代碼KRA
諮詢委員會CV
決定Substantially Equivalent

器材摘要

CrossCath Support Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2016-07-29 under 510(k) number K161801. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CrossCath Support Catheter?

CrossCath Support Catheter is a medical device that received FDA 510(k) clearance on 2016-07-29. The listed applicant is Cook Incorporated. The 510(k) number is K161801.

When did CrossCath Support Catheter receive FDA 510(k) clearance?

CrossCath Support Catheter received FDA 510(k) clearance on 2016-07-29, under 510(k) number K161801.

Who is the listed applicant for CrossCath Support Catheter?

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

What is the FDA product code for CrossCath Support Catheter?

The FDA product code for CrossCath Support Catheter is KRA.

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其他以 Cook Incorporated 為申請人之記錄

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相關器械(代碼:KRA)

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。

官方來源

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