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

    KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES

    K Number: K041151 · Decision Jul 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    5
    Review Days
    80

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    Basic Information

    Device Name
    KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES
    K Number
    K041151
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kerberos Proximal Solutions, Inc.
    Date Received
    May 3, 2004
    Decision Date
    July 22, 2004
    Product Code
    DQY
    Advisory Committee
    Cardiovascular
    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
    DQY Catheter, Percutaneous

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    Other Clearances by Kerberos Proximal Solutions, Inc.

    K Number Device Name
    K062275 RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135
    K050130 KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM
    K041123 RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703
    K041291 RINSPIRATION SYSTEM