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FDA 510(k)

遙感微導管

K 號:K182360 · 2018-11-09

決定日期2018-11-09
產品代碼DQY
諮詢委員會履歷
決定相當於

器材摘要

Teleport Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Orbusneich Medical Trading, Inc.. It received FDA 510(k) clearance on 2018-11-09 under 510(k) number K182360. 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 Microcatheter?

Teleport Microcatheter is a medical device that received FDA 510(k) clearance on 2018-11-09. The listed applicant is Orbusneich Medical Trading, Inc.. The 510(k) number is K182360.

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

Teleport Microcatheter received FDA 510(k) clearance on 2018-11-09, under 510(k) number K182360.

Who is the listed applicant for Teleport Microcatheter?

The FDA 510(k) record lists Orbusneich Medical Trading, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Teleport Microcatheter?

The FDA product code for Teleport Microcatheter is DQY.

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其他以 Orbusneich Medical Trading, Inc. 為申請人之記錄

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相關器械(代碼:DQY)

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官方來源

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