BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇾 Malaysia

    Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled

    K Number: K252643 · Decision May 15, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    201
    Applicant Total
    2
    Review Days
    267

    Basic Information

    Device Name
    Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled
    K Number
    K252643
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5260
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Teleflex Medical Sdn. Bhd.
    Date Received
    August 21, 2025
    Decision Date
    May 15, 2026
    Product Code
    CAH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CAH Filter, Bacterial, Breathing-Circuit

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