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

    EUPALAMUS DEFLECTABLE STYLET, MODEL 01545

    K Number: K002534 · Decision Oct 18, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    27
    Applicant Total
    1
    Review Days
    63

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    EUPALAMUS DEFLECTABLE STYLET, MODEL 01545
    K Number
    K002534
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1380
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eupalamus, LLC
    Date Received
    August 16, 2000
    Decision Date
    October 18, 2000
    Product Code
    DRB
    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
    DRB Stylet, Catheter

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DRB), ordered by most recent decision date.

    Arrow Stiffening Stylet

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Biotronik Stylets

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GaltTWS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Liberator Beacon Tip Locking Stylet

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LLD EZ

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all