FDA 510(k)

Indigo® 吸引系統 – 吸引針 6X

K 號：K242319 · 2024-09-03

決定日期2024-09-03

產品代碼QEW

諮詢委員會履歷

決定相當於

器材摘要

Indigo® Aspiration System – Aspiration Catheter 6X is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2024-09-03 under 510(k) number K242319. 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 – Aspiration Catheter 6X?

Indigo® Aspiration System – Aspiration Catheter 6X is a medical device that received FDA 510(k) clearance on 2024-09-03. The listed applicant is Penumbra, Inc.. The 510(k) number is K242319.

When did Indigo® Aspiration System – Aspiration Catheter 6X receive FDA 510(k) clearance?

Indigo® Aspiration System – Aspiration Catheter 6X received FDA 510(k) clearance on 2024-09-03, under 510(k) number K242319.

Who is the listed applicant for Indigo® Aspiration System – Aspiration Catheter 6X?

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 – Aspiration Catheter 6X?

The FDA product code for Indigo® Aspiration System – Aspiration Catheter 6X 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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