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

    Lynx Aspiration Catheter System

    K Number: K254276 · Decision May 7, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    108
    Applicant Total
    1
    Review Days
    128

    Basic Information

    Device Name
    Lynx Aspiration Catheter System
    K Number
    K254276
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Q’Apel Medical, Inc.
    Date Received
    December 30, 2025
    Decision Date
    May 7, 2026
    Product Code
    NRY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NRY Catheter, Thrombus Retriever

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