BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    TAKY-SPIKE PLUS

    K Number: K974198 · Decision Dec 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    205
    Applicant Total
    2
    Review Days
    42

    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
    TAKY-SPIKE PLUS
    K Number
    K974198
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Clinico
    Date Received
    November 10, 1997
    Decision Date
    December 22, 1997
    Product Code
    LHI
    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
    LHI Set, I.V. Fluid Transfer

    Similar 510(k) Clearances

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

    ADRx™ Admixture Device

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Vial Adapter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Medline Bag Decanter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FlowArt® Vial Access Device Vented

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HyHub™ and HyHub™ Duo Vial Access Devices

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

    Other Clearances by Clinico

    K Number Device Name
    K041919 PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606