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

    CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12

    K Number: K041890 · Decision Sep 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    53
    Applicant Total
    2
    Review Days
    72

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    Basic Information

    Device Name
    CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12
    K Number
    K041890
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cryocor, Inc.
    Date Received
    July 12, 2004
    Decision Date
    September 22, 2004
    Product Code
    OCL
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

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    Other Clearances by Cryocor, Inc.

    K Number Device Name
    K040552 MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130