FDA 510(k)

PUREVUE™ 快速連接針筒系統托盤；PUREVUE™ 快速連接針筒系統蓋

K 號：K253791 · 2026-02-26

決定日期2026-02-26

產品代碼KCT

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Mitek, Inc.. It received FDA 510(k) clearance on 2026-02-26 under 510(k) number K253791. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid?

PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid is a medical device that received FDA 510(k) clearance on 2026-02-26. The listed applicant is DePuy Mitek, Inc.. The 510(k) number is K253791.

When did PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid receive FDA 510(k) clearance?

PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid received FDA 510(k) clearance on 2026-02-26, under 510(k) number K253791.

Who is the listed applicant for PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid?

The FDA 510(k) record lists DePuy Mitek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid?

The FDA product code for PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid is KCT.

其他以 DePuy Mitek, 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。

K233675FMS VUE™ 液體管理及組織清創系統

相關器械（代碼：KCT）

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。

K253988LiteSet 盤子Nobel Biocare AB K261935外科及義肢托盤Dentsply Sirona, Inc.K253187SteriBest® 過濾消毒托盤系統Mastel Surgical K252854SteriTite容器系統搭配MediTray產品Case Medical, Inc.K260726斯特羅曼® ProClean™ 裝籠 (041.800 ; 041.801)Institut Straumann AG K251614不鏽鋼外科工具組Dentsply Sirona, Inc.

官方來源

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