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

    GRAFT MARKER RING

    K Number: K001915 · Decision Apr 27, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    2
    Applicant Total
    27
    Review Days
    308

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    Basic Information

    Device Name
    GRAFT MARKER RING
    K Number
    K001915
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    T. Korossurgical Instruments Corp.
    Date Received
    June 23, 2000
    Decision Date
    April 27, 2001
    Product Code
    MAB
    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
    MAB Marker, Cardiopulmonary Bypass (Vein Marker)

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    K935529 CERVICAL SELF-RETAINING RETRACTOR
    K926585 THOROCOSCOPY SELF-RETAINING RETRACTOR
    K931262 REUSABLE/INTERCHANGEABLE SHAFT, ENDOSCOPIC SCISSOR
    K926583 REUSABLE ENDOSCOPIC SCISSORS, GRASPER-MONOPOLAR
    K931259 ENDOSCOPIC OR THORASCOPIC FORCEPS
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