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

    BNLE Hydrophilic Jacketed Peripheral Guidewire

    K Number: K232662 · Decision May 14, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    2
    Review Days
    257

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    Basic Information

    Device Name
    BNLE Hydrophilic Jacketed Peripheral Guidewire
    K Number
    K232662
    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
    August 31, 2023
    Decision Date
    May 14, 2024
    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
    K221390 BNLE Access Guidewire