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

    Raptor Aspiration Catheter; Balt Aspiration Tubing Set

    K Number: K243948 · Decision Jun 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    108
    Applicant Total
    18
    Review Days
    162

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    Basic Information

    Device Name
    Raptor Aspiration Catheter; Balt Aspiration Tubing Set
    K Number
    K243948
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Balt USA, LLC
    Date Received
    December 23, 2024
    Decision Date
    June 3, 2025
    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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