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

    RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135

    K Number: K062275 · Decision Sep 20, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    91
    Applicant Total
    5
    Review Days
    44

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    Basic Information

    Device Name
    RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135
    K Number
    K062275
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Kerberos Proximal Solutions, Inc.
    Date Received
    August 7, 2006
    Decision Date
    September 20, 2006
    Product Code
    QEZ
    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
    QEZ Aspiration Thrombectomy Catheter

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    Other Clearances by Kerberos Proximal Solutions, Inc.

    K Number Device Name
    K050130 KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM
    K041123 RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703
    K041151 KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES
    K041291 RINSPIRATION SYSTEM