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

    INTRACOIL SELF-EXPANDING PERIPHERAL STENT

    K Number: K021563 · Decision May 31, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    44
    Applicant Total
    8
    Review Days
    18

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    Basic Information

    Device Name
    INTRACOIL SELF-EXPANDING PERIPHERAL STENT
    K Number
    K021563
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3720
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sulzer Intratherapeutics, Inc.
    Date Received
    May 13, 2002
    Decision Date
    May 31, 2002
    Product Code
    JCT
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JCT Prosthesis, Tracheal, Expandable

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    Other Clearances by Sulzer Intratherapeutics, Inc.

    K Number Device Name
    K023243 MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
    K021729 MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
    K020528 INTRASTENT LD (LARGE DIAMETER) STENT
    K014136 MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
    K011806 PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
    K012347 PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
    K012066 PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY