BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER

    K Number: K033084 · Decision Dec 19, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    50
    Applicant Total
    7
    Review Days
    81

    Basic Information

    Device Name
    WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER
    K Number
    K033084
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6110
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    PORTEX LTD.
    Date Received
    September 29, 2003
    Decision Date
    December 19, 2003
    Product Code
    MQF
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQF Catheter, Assisted Reproduction

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    Other Clearances by PORTEX LTD.

    K Number Device Name
    K040014 PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY
    K032112 P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)
    K032716 PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)
    K030570 BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
    K030381 PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA
    K031622 WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS