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

    CATHLAB SILICONE OCCLUSION BALLOON CATHETER

    K Number: K910916 · Decision Jun 24, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    11
    Applicant Total
    8
    Review Days
    111

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    Basic Information

    Device Name
    CATHLAB SILICONE OCCLUSION BALLOON CATHETER
    K Number
    K910916
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1370
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cathlab Corp.
    Date Received
    March 5, 1991
    Decision Date
    June 24, 1991
    Product Code
    DQT
    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
    DQT Occluder, Catheter Tip

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    Other Clearances by Cathlab Corp.

    K Number Device Name
    K910917 CATHLAB SILICONE BILIARY 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)