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

    HEART TECHNOLOGY WIRECLIP

    K Number: K914581 · Decision Jan 6, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    4
    Review Days
    82

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    Basic Information

    Device Name
    HEART TECHNOLOGY WIRECLIP
    K Number
    K914581
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Heart Technology, Inc.
    Date Received
    October 16, 1991
    Decision Date
    January 6, 1992
    Product Code
    DQX
    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
    DQX Wire, Guide, Catheter

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    Other Clearances by Heart Technology, Inc.

    K Number Device Name
    K933238 ROTABLATOR, MODIFICATION
    K913450 HEART TECHNOLOGY ROTABLATOR WIRECLIP
    K901206 ROTABLATOR