BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS

    K Number: K030788 · Decision Jul 12, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    19
    Applicant Total
    6
    Review Days
    122

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    Basic Information

    Device Name
    KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS
    K Number
    K030788
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4475
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Geister Medizin Technik GmbH
    Date Received
    March 12, 2003
    Decision Date
    July 12, 2003
    Product Code
    DWP
    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
    DWP Dilator, Vessel, Surgical

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