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

    LEONARD PERIPHERAL VENOUS PRESSURE CATH

    K Number: K821996 · Decision Jul 30, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    98
    Applicant Total
    39
    Review Days
    23

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    Basic Information

    Device Name
    LEONARD PERIPHERAL VENOUS PRESSURE CATH
    K Number
    K821996
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Norton Performance Plastics Corp.
    Date Received
    July 7, 1982
    Decision Date
    July 30, 1982
    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 Norton Performance Plastics Corp.

    K Number Device Name
    K853791 NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000
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    K851299 CORRECT FLO
    K842858 FLUID ADMINISTRATION LINE W/SPIKE 14-923
    K841828 CENTRAL VENOUS CATHETER W/BIG-GARD
    K840240 MICROFUSE INTRAVENOUS CATHETER SET
    K831587 TEMP. REPAIR KIT-DUAL LUMEN CATHETER
    K831698 DISPOSABLE PRESSURE TRANSDUCER#14004195
    K830788 CENTRAL VEIN CATHERIZATION KIT-14-690-
    K830813 FRENCH PERCUTANEOUS SHEATH INTRODUCER
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