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

    RINSPIRATION SYSTEM

    K Number: K041291 · Decision May 21, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    5
    Review Days
    7

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    Basic Information

    Device Name
    RINSPIRATION SYSTEM
    K Number
    K041291
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kerberos Proximal Solutions, Inc.
    Date Received
    May 14, 2004
    Decision Date
    May 21, 2004
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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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
    K041151 KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES