FDA 510(k)

FlexCath Contour™ 可導鞘

K 號：K232321 · 2023-10-31

決定日期2023-10-31

產品代碼DRA

諮詢委員會履歷

決定相當於

器材摘要

FlexCath Contour™ Steerable Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2023-10-31 under 510(k) number K232321. The device is classified under product code DRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FlexCath Contour™ Steerable Sheath?

FlexCath Contour™ Steerable Sheath is a medical device that received FDA 510(k) clearance on 2023-10-31. The listed applicant is Medtronic, Inc.. The 510(k) number is K232321.

When did FlexCath Contour™ Steerable Sheath receive FDA 510(k) clearance?

FlexCath Contour™ Steerable Sheath received FDA 510(k) clearance on 2023-10-31, under 510(k) number K232321.

Who is the listed applicant for FlexCath Contour™ Steerable Sheath?

FDA 510(k) 記錄將美敦力公司（Medtronic, Inc.）列為申請人。這並不單獨確立該設備製造商。

What is the FDA product code for FlexCath Contour™ Steerable Sheath?

The FDA product code for FlexCath Contour™ Steerable Sheath is DRA.

其他以 Medtronic, Inc. 為申請人之記錄

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相關器械（代碼：DRA）

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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