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

    HOLLOW MOTOR DRIVE UNIT

    K Number: K901601 · Decision Jul 6, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    14
    Review Days
    91

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    Basic Information

    Device Name
    HOLLOW MOTOR DRIVE UNIT
    K Number
    K901601
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Devices For Vascular Intervention, Inc.
    Date Received
    April 6, 1990
    Decision Date
    July 6, 1990
    Product Code
    LIT
    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
    LIT Catheter, Angioplasty, Peripheral, Transluminal

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    Other Clearances by Devices For Vascular Intervention, Inc.

    K Number Device Name
    K935929 MICROTRACK
    K920707 HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLER
    K914422 DEVICES FOR VASCU INTERVENT ROTAT HEMOSTAT VALVE
    K911678 ROTATING HEMOSTATIC VALVE
    K910205 LP-60 LOW PRESSURE INFLATION DEVICE
    K883933 INTRODUCING CATHETER
    K883981 GUIDING CATHETER (TIP SOFTNESS CHANGE)
    K883916 ROTATING HEMOSTATIC VALVE
    K883346 SIMPSON PERIPHERAL ATHEROCATH W/ADDIT. SIZE 13F
    K881088 ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM)
    Search all 14 clearances from Devices For Vascular Intervention, Inc. →