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

    SEPTISLEEVE

    K Number: K820883 · Decision Apr 29, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    98
    Applicant Total
    27
    Review Days
    30

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    Basic Information

    Device Name
    SEPTISLEEVE
    K Number
    K820883
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Argon Medical Corp.
    Date Received
    March 30, 1982
    Decision Date
    April 29, 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 Argon Medical Corp.

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    K884375 TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER
    K882221 OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE
    K871297 KADIR HI-TORQUE GUIDE WIRE
    K853312 ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES
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