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

    K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)

    K Number: K123344 · Decision Mar 7, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    437
    Registration Numbers
    437
    Same Product Code
    1167
    Applicant Total
    8
    Review Days
    127

    Basic Information

    Device Name
    K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)
    K Number
    K123344
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KAWASUMI LABORATORIES, INC.
    Date Received
    October 31, 2012
    Decision Date
    March 7, 2013
    Product Code
    FPA
    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
    FPA Set, Administration, Intravascular

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    Other Clearances by KAWASUMI LABORATORIES, INC.

    K Number Device Name
    K100720 K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING
    K102994 K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR
    K073257 KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR
    K061197 KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER
    K060580 K-SHIELD PORT ACCESS INFUSION SET
    K023917 WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR
    K022110 KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS.