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

    CENTURION UMBILICAL CATHETER

    K Number: K942353 · Decision Aug 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    17
    Same Product Code
    33
    Applicant Total
    16
    Review Days
    455

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    Basic Information

    Device Name
    CENTURION UMBILICAL CATHETER
    K Number
    K942353
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tri-State Hospital Supply Corp.
    Date Received
    May 17, 1994
    Decision Date
    August 15, 1995
    Product Code
    FOS
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FOS Catheter, Umbilical Artery

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    Other Clearances by Tri-State Hospital Supply Corp.

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    K945977 CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING
    K931748 CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS
    K935491 CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER)
    K923812 CENTURION DISPOSABLE INSTRUMENTS
    K910906 CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS
    K897100 CENTURION VAGINAL SPECULUM
    K896320 CENTURION KLEEN-NEEDLE SYSTEM
    K893647 COPOLYESTER FILM DRESSING
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