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

    BNLE Access Guidewire

    K Number: K221390 · Decision Apr 28, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    2
    Review Days
    350

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    Basic Information

    Device Name
    BNLE Access Guidewire
    K Number
    K221390
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomerics Nle
    Date Received
    May 13, 2022
    Decision Date
    April 28, 2023
    Product Code
    DQX
    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
    DQX Wire, Guide, Catheter

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    Other Clearances by Biomerics Nle

    K Number Device Name
    K232662 BNLE Hydrophilic Jacketed Peripheral Guidewire