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

    FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100

    K Number: K090621 · Decision Jun 19, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    11
    Review Days
    102

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    Basic Information

    Device Name
    FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100
    K Number
    K090621
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Flowcardia, Inc.
    Date Received
    March 9, 2009
    Decision Date
    June 19, 2009
    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 Flowcardia, Inc.

    K Number Device Name
    K092175 THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200
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    K091119 MODIFICATION TO THE CROSSER SYSTEM
    K080849 MICROSHEATH LP AND LP-AT
    K080765 CROSSER LP SYSTEM
    K073289 MICROSHEATH XL CATHETERS
    K072776 THE CROSSER SYSTEM
    K062868 THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02
    K051580 VP SHEATH
    K051062 VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO
    Search all 11 clearances from Flowcardia, Inc. →