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

    CATHLAB SILICONE BILIARY BALLOON CATHETER

    K Number: K910917 · Decision Aug 2, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    25
    Applicant Total
    8
    Review Days
    150

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    Basic Information

    Device Name
    CATHLAB SILICONE BILIARY BALLOON CATHETER
    K Number
    K910917
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Cathlab Corp.
    Date Received
    March 5, 1991
    Decision Date
    August 2, 1991
    Product Code
    GCA
    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
    GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

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    Other Clearances by Cathlab Corp.

    K Number Device Name
    K910916 CATHLAB SILICONE OCCLUSION BALLOON CATHETER
    K905139 CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER
    K897051 MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATH
    K897184 3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS
    K893435 SILICONE FLOW-DIRECTED THERMODILUTION CATHETER
    K893680 SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.
    K881455 EMBOLECTOMY CATHETER(MODIFIED)