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

    C2 CryoBalloon Focal Pear Catheter

    K Number: K160994 · Decision May 19, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    7
    Review Days
    41

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    Basic Information

    Device Name
    C2 CryoBalloon Focal Pear Catheter
    K Number
    K160994
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C2 Therapeutics, Inc.
    Date Received
    April 8, 2016
    Decision Date
    May 19, 2016
    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, Inc.

    K Number Device Name
    K163684 C2 CryoBalloon Ablation System
    K161202 C2 Cryoballoon Ablation System
    K152329 Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System
    K153541 Coldplay CryoBalloon® Ablation System
    K152140 Boa Endoscopic Valve
    K151054 Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System