FDA 510(k)

藍色抽吸系統

K 號：K163618 · 2017-05-24

決定日期2017-05-24

產品代碼QEX

諮詢委員會履歷

決定Unknown

器材摘要

INDIGO Aspiration System is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2017-05-24 under 510(k) number K163618. The device is classified under product code QEX. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

常見問題

What is the INDIGO Aspiration System?

INDIGO Aspiration System is a medical device that received FDA 510(k) clearance on 2017-05-24. The listed applicant is Penumbra, Inc.. The 510(k) number is K163618.

When did INDIGO Aspiration System receive FDA 510(k) clearance?

INDIGO Aspiration System received FDA 510(k) clearance on 2017-05-24, under 510(k) number K163618.

Who is the listed applicant for INDIGO Aspiration System?

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

What is the FDA product code for INDIGO Aspiration System?

The FDA product code for INDIGO Aspiration System is QEX.

其他以 Penumbra, Inc. 為申請人之記錄

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K250690Penumbra 系統（Thunderbolt 吸引管）K260599INDIGO® 吸引系統 – INDIGO 鏈接 K251949INDIGO® 吸引系統 - 雷電閃吸管連結版 K252612INDIGO® 吸引系統 – 雷電閃吸管；INDIGO® 吸引系統 – 雷電閃吸管 K250079Ruby XL 系統 K242104Penumbra 系統（再灌流導管 RED 72）

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相關器械（代碼：QEX）

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。

K253407NeVa 靜脈血栓切除裝置Vesalio, Inc.K171493MegaVac機械性血栓切除系統Capture Vascular, Inc.

官方來源

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