FDA 510(k)

遙傳XT微導管

K 號：K231608 · 2024-01-07

申請人OrbusNeich Medical (Shenzhen) Co., Ltd.

決定日期2024-01-07

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

Teleport XT Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2024-01-07 under 510(k) number K231608. 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 Teleport XT Microcatheter?

Teleport XT Microcatheter is a medical device that received FDA 510(k) clearance on 2024-01-07. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd.. The 510(k) number is K231608.

When did Teleport XT Microcatheter receive FDA 510(k) clearance?

Teleport XT Microcatheter received FDA 510(k) clearance on 2024-01-07, under 510(k) number K231608.

Who is the listed applicant for Teleport XT Microcatheter?

FDA 510(k) 記錄將OrbusNeich Medical (Shenzhen) Co., Ltd. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Teleport XT Microcatheter?

The FDA product code for Teleport XT Microcatheter is DQY.

其他以 OrbusNeich Medical (Shenzhen) Co., Ltd. 為申請人之記錄

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相關器械（代碼：DQY）

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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