FDA 510(k)

MIDWAY 選送導管（MIDWAY 43 選送導管；MIDWAY 62 選送導管）

K 號：K233201 · 2024-03-27

決定日期2024-03-27

產品代碼QJP

諮詢委員會履歷

決定相當於

器材摘要

MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2024-03-27 under 510(k) number K233201. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)?

MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) is a medical device that received FDA 510(k) clearance on 2024-03-27. The listed applicant is Penumbra, Inc.. The 510(k) number is K233201.

When did MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) receive FDA 510(k) clearance?

MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) received FDA 510(k) clearance on 2024-03-27, under 510(k) number K233201.

Who is the listed applicant for MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)?

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 MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)?

The FDA product code for MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) is QJP.

其他以 Penumbra, Inc. 為申請人之記錄

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相關器械（代碼：QJP）

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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