BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE

    K Number: K030303 · Decision Apr 29, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    6
    Review Days
    90

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    Basic Information

    Device Name
    FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE
    K Number
    K030303
    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
    Cryocath Technologies, Inc.
    Date Received
    January 29, 2003
    Decision Date
    April 29, 2003
    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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