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

    LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.

    K Number: K960866 · Decision Apr 5, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    63
    Applicant Total
    42
    Review Days
    32

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    Basic Information

    Device Name
    LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.
    K Number
    K960866
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lake Region Mfg., Inc.
    Date Received
    March 4, 1996
    Decision Date
    April 5, 1996
    Product Code
    KNY
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KNY Accessories, Catheter, G-U

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    Other Clearances by Lake Region Mfg., Inc.

    K Number Device Name
    K092965 TRAILRUNNER GUIDEWIRES
    K082922 FREEWAY AND RAILRUNNER GUIDEWIRES
    K081708 TAXI ENDOSCOPIC GUIDEWIRE
    K080144 MANDREL GUIDEWIRES OR M-WIRES
    K073655 PEGASUS STEERABLE (PTCA) GUIDEWIRE
    K060454 TITAN GUIDEWIRE
    K052347 TITAN STEERABLE (PTCA) GUIDEWIRE
    K042338 CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE
    K041624 PTCA STEERABLE HYDROPHILIC GUIDEWIRE
    K040825 LAKE REGION HYDROPHILIC GUIDEWIRE
    Search all 42 clearances from Lake Region Mfg., Inc. →