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FDA 510(k)

Intri26 引導鞘

K 號:K252508 · 2025-12-17

決定日期2025-12-17
產品代碼DYB
諮詢委員會履歷
決定相當於

器材摘要

Intri26 Introducer Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Inari Medical, Inc.. It received FDA 510(k) clearance on 2025-12-17 under 510(k) number K252508. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Intri26 Introducer Sheath?

Intri26 Introducer Sheath is a medical device that received FDA 510(k) clearance on 2025-12-17. The listed applicant is Inari Medical, Inc.. The 510(k) number is K252508.

When did Intri26 Introducer Sheath receive FDA 510(k) clearance?

Intri26 Introducer Sheath received FDA 510(k) clearance on 2025-12-17, under 510(k) number K252508.

Who is the listed applicant for Intri26 Introducer Sheath?

FDA 510(k) 記錄將 Inari Medical, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Intri26 Introducer Sheath?

The FDA product code for Intri26 Introducer Sheath is DYB.

相關臨床試驗

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其他以 Inari Medical, Inc. 為申請人之記錄

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相關器械(代碼:DYB)

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。

官方來源

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