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

    ELPH INJECTION SYSTEM

    K Number: K022116 · Decision Jul 26, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    8
    Review Days
    25

    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
    ELPH INJECTION SYSTEM
    K Number
    K022116
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mallinckrodt Inc., Liebel-Flarsheim Business
    Date Received
    July 1, 2002
    Decision Date
    July 26, 2002
    Product Code
    DXT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXT Injector And Syringe, Angiographic

    Similar 510(k) Clearances

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

    Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Extension tube

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Mallinckrodt Inc., Liebel-Flarsheim Business

    K Number Device Name
    K082212 SYRINGE WITH HANDI-FIL
    K073592 OPTISTAR ELITE INJECTION SYSTEM
    K063503 OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION
    K042744 OPTIV ANTAGE DH POWER INJECTION SYSTEM
    K031339 OPTIBOLUS
    K984088 OPTISTAR MR INJECTOR SYSTEM
    K963071 ANGIOMAT ILLUMENA