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

    ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE

    K Number: K850861 · Decision Feb 18, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    63
    Review Days
    354

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    Basic Information

    Device Name
    ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE
    K Number
    K850861
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medical Components, Inc.
    Date Received
    March 1, 1985
    Decision Date
    February 18, 1986
    Product Code
    DXT
    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
    DXT Injector And Syringe, Angiographic

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    Other Clearances by Medical Components, Inc.

    K Number Device Name
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    K132880 MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE
    K131687 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET
    K130687 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
    K130923 5F DIGNITY CT TITANIUM PORT
    K124046 VALVED TEARAWAY INTRODUCER GENERATION II
    K123617 3F PRO-PICC
    K122423 VASU-PICC
    K121848 SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM
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