FDA 510(k)

PUREVUE™ 快速连接导管系统托盘；PUREVUE™ 快速连接导管系统盖

K号: K253791 · 2026-02-26

决定日期2026-02-26

产品代码KCT

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明DePuy Mitek, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K233675FMS VUE™ 液体管理和组织清创系统

官方来源

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