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

    LOCALISA CARDIAC NAVIGATION SYSTEM

    K Number: K002869 · Decision Mar 27, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    12
    Review Days
    195

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    Basic Information

    Device Name
    LOCALISA CARDIAC NAVIGATION SYSTEM
    K Number
    K002869
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Surgical Navigation Technologies
    Date Received
    September 13, 2000
    Decision Date
    March 27, 2001
    Product Code
    DQK
    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
    DQK Computer, Diagnostic, Programmable

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    Other Clearances by Medtronic Surgical Navigation Technologies

    K Number Device Name
    K050438 STEALTHSTATION SYSTEM UPDATE
    K043088 MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE
    K030552 IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM
    K030106 STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE
    K022126 CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM
    K021980 HIP MODULE FOR THE STEALTHSTATION SYSTEM
    K022414 STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE
    K020338 STEALTHSTATION WITH FLUOROMERGE SOFTWARE
    K012937 KNEE MODULE FOR THE STEALTHSTATION SYSTEM
    K003201 STEALTHSTATION TREATMENT GUIDANCE PLATFORM
    Search all 12 clearances from Medtronic Surgical Navigation Technologies →