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

    ANGIOLAZ ANGIOSCOPE CATHETER

    K Number: K913129 · Decision Dec 27, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    40
    Applicant Total
    10
    Review Days
    164

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    Basic Information

    Device Name
    ANGIOLAZ ANGIOSCOPE CATHETER
    K Number
    K913129
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Angiolaz, Inc.
    Date Received
    July 16, 1991
    Decision Date
    December 27, 1991
    Product Code
    LYK
    Advisory Committee
    Gastroenterology, Urology
    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
    LYK Angioscope

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    Other Clearances by Angiolaz, Inc.

    K Number Device Name
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    K982409 VES 1501-M
    K981819 ANGIOLAZ VES-1CAM
    K981821 VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR
    K981827 VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM
    K933868 ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES
    K902329 ULTRA-VU ANGIOSCOPE