FDA 510(k)

Indigo® 吸引系統 – 雷霆吸引管

K 號：K223186 · 2023-02-13

決定日期2023-02-13

產品代碼QEW

諮詢委員會履歷

決定相當於

器材摘要

Indigo® Aspiration System – Lightning Bolt Aspiration Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2023-02-13 under 510(k) number K223186. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Indigo® Aspiration System – Lightning Bolt Aspiration Tubing?

Indigo® Aspiration System – Lightning Bolt Aspiration Tubing is a medical device that received FDA 510(k) clearance on 2023-02-13. The listed applicant is Penumbra, Inc.. The 510(k) number is K223186.

When did Indigo® Aspiration System – Lightning Bolt Aspiration Tubing receive FDA 510(k) clearance?

Indigo® Aspiration System – Lightning Bolt Aspiration Tubing received FDA 510(k) clearance on 2023-02-13, under 510(k) number K223186.

Who is the listed applicant for Indigo® Aspiration System – Lightning Bolt Aspiration Tubing?

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 – Lightning Bolt Aspiration Tubing?

The FDA product code for Indigo® Aspiration System – Lightning Bolt Aspiration Tubing is QEW.

其他以 Penumbra, Inc. 為申請人之記錄

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。

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：QEW）

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。

K253419Triever Duo 穿刺針管Inari Medical, Inc.K261800Helo Max 靈栓切除系統 (HEL2090)Endovascular Engineering K262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc.K261523Vertex™ 靈栓切除系統Jupiter Endovascular K260599INDIGO® 吸引系統 – INDIGO 鏈接Penumbra, Inc.K251949INDIGO® 吸引系統 - 雷電閃吸管連結版Penumbra, Inc.

官方來源

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