FDA 510(k)

上流回溯交叉導管

K 號：K182937 · 2019-05-23

申請人Upstream Peripheral Technologies, Ltd.

決定日期2019-05-23

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

Upstream GoBack Crossing Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Upstream Peripheral Technologies, Ltd.. It received FDA 510(k) clearance on 2019-05-23 under 510(k) number K182937. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Upstream GoBack Crossing Catheter?

Upstream GoBack Crossing Catheter is a medical device that received FDA 510(k) clearance on 2019-05-23. The listed applicant is Upstream Peripheral Technologies, Ltd.. The 510(k) number is K182937.

When did Upstream GoBack Crossing Catheter receive FDA 510(k) clearance?

Upstream GoBack Crossing Catheter received FDA 510(k) clearance on 2019-05-23, under 510(k) number K182937.

Who is the listed applicant for Upstream GoBack Crossing Catheter?

The FDA 510(k) record lists Upstream Peripheral Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Upstream GoBack Crossing Catheter?

The FDA product code for Upstream GoBack Crossing Catheter is DQY.

其他以 Upstream Peripheral Technologies, Ltd. 為申請人之記錄

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K211802GoBack 跨越導管

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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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