BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CRYOBALLOON ABLATION SYSTEM

    K Number: K101825 · Decision Sep 29, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    3
    Review Days
    90

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    Basic Information

    Device Name
    CRYOBALLOON ABLATION SYSTEM
    K Number
    K101825
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C2 Therapeutics
    Date Received
    July 1, 2010
    Decision Date
    September 29, 2010
    Product Code
    GEH
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GEH Unit, Cryosurgical, Accessories

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    Other Clearances by C2 Therapeutics

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    K150083 Sidecar External Working Channel
    K131523 CRYOBALLOON FOCAL ABLATION SYSTEM