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

    COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR

    K Number: K133600 · Decision Apr 30, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    14
    Review Days
    156

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    Basic Information

    Device Name
    COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR
    K Number
    K133600
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coeur, Inc.
    Date Received
    November 25, 2013
    Decision Date
    April 30, 2014
    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

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    Other Clearances by Coeur, Inc.

    K Number Device Name
    K170431 CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip
    K161471 MR Syringe Dual Pack for Solaris Injectors
    K150902 330psi Extension Y-Line with Dual Check Valve
    K142745 125mL CT Syringe
    K140469 MR SYRINGE DUAL PACK
    K120892 DISPOSABLE 330PSI EXTENSION LINES
    K113498 DISPOSABLE TORQUE DEVICE
    K113132 DISPOSABLE HEMOSTATIC Y-CONNECTORS
    K090487 DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150
    K070798 ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS
    Search all 14 clearances from Coeur, Inc. →