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

    SILICONE FLOW-DIRECTED THERMODILUTION CATHETER

    K Number: K893435 · Decision Sep 26, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    98
    Applicant Total
    8
    Review Days
    147

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    Basic Information

    Device Name
    SILICONE FLOW-DIRECTED THERMODILUTION CATHETER
    K Number
    K893435
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cathlab Corp.
    Date Received
    May 2, 1989
    Decision Date
    September 26, 1989
    Product Code
    DYG
    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
    DYG Catheter, Flow Directed

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    Other Clearances by Cathlab Corp.

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