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

    KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS.

    K Number: K022110 · Decision Sep 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    11
    Review Days
    76

    Basic Information

    Device Name
    KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS.
    K Number
    K022110
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kawasumi Laboratories, Inc.
    Date Received
    June 28, 2002
    Decision Date
    September 12, 2002
    Product Code
    LJT
    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
    LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

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    Other Clearances by Kawasumi Laboratories, Inc.

    K Number Device Name
    K190485 Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
    K190233 K-Shield Advantage Port Access Infusion Set (PAIS)
    K172957 Kawasumi Laboratories Blood Drawing Kit (BDK) System
    K123344 K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)
    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
    Search all 11 clearances from Kawasumi Laboratories, Inc. →