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510(k) Data Aggregation

    K Number
    K253791

    Validate with FDA (Live)

    Device Name
    PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid
    Manufacturer
    DePuy Mitek, Inc.
    Date Cleared
    2026-02-26

    (90 days)

    Product Code
    KCT
    Regulation Number
    880.6850
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    K241927
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect Cannula System Lid are used to store, organize, and transport PUREVUE™ Quick Connect Cannula System instruments during sterilization and surgical procedures. The tray and lid are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier wrap.

    The tray and lid were validated for a maximum load of 22.1 lb (tray + contents + lid + wrap).

    Device Description

    The PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect Cannula System Lid are a modular, reusable tray and lid system intended for use in health care facilities for the purpose of containing medical devices for sterilization. The system is composed of two pieces, designed to be integrated into a single unit that contains and protects PUREVUE™ Quick Connect Cannula System instruments during sterilization and transport. All components are perforated for steam penetration.

    AI/ML Overview

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