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

    PERCUTANEOUS SHEATH INTRODUCER TRAYS

    K Number: K833574 · Decision Jan 11, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    16
    Review Days
    91

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    Basic Information

    Device Name
    PERCUTANEOUS SHEATH INTRODUCER TRAYS
    K Number
    K833574
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Intermed, Inc.
    Date Received
    October 12, 1983
    Decision Date
    January 11, 1984
    Product Code
    DQX
    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
    DQX Wire, Guide, Catheter

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    Other Clearances by Intermed, Inc.

    K Number Device Name
    K900857 NON STERILE PARENTERAL SUPPLY KIT
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    K833126 DRESSING CHANGE TRAYS
    K833573 CENTRAL VEIN CATH. TRAY CC-20-1420
    K833139 ACUTE HEMODIALYSIS TRAYS
    K833059 SUCTION CATHETER TRAYS
    K821269 TRACHEOSTOMY CARE TRAYS
    K791427 CATHETERIZATION TRAYS FOLEY AND URETHRAL
    K791426 PERITONEAL PAC
    K781748 IRRIGATION TRAY
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