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

    STERILE DESIGN-CUSTOM STERILE IV KIT

    K Number: K842351 · Decision Oct 15, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    10
    Review Days
    122

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    STERILE DESIGN-CUSTOM STERILE IV KIT
    K Number
    K842351
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Sterile Design, Inc.
    Date Received
    June 15, 1984
    Decision Date
    October 15, 1984
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FPA), ordered by most recent decision date.

    iiSure Infusion Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PuraCath Firefly Needleless Connector IT (9005)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD Alaris Pump Infusion Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EZ™ IV Administration Set

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Sterile Design, Inc.

    K Number Device Name
    K934688 STERILE DESIGN
    K841960 CARDIO METRICS INVASIVE PRESSURE MONIT
    K842356 CUSTOM STERILE PROCEDURE KITS
    K841959 CARDIO METRIC CUSTOM PERFUSION TUBING
    K841958 CARDIO METRICS CARDIOTOMY RESERVOIR
    K834239 SDI C-FLEX STERILE LIGHT HANDLE
    K834237 GRADUATED GUIDE WIRE BOWL 8
    K813437 PAN SET
    K791738 CUSTOM DRESSING CHANGE TRAYS