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

    SafeCross Transseptal Puncture and Introducer (TSP/I) System

    K Number: K203459 · Decision Jul 6, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    2
    Review Days
    224

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    Basic Information

    Device Name
    SafeCross Transseptal Puncture and Introducer (TSP/I) System
    K Number
    K203459
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    East End Medical I, LLC
    Date Received
    November 24, 2020
    Decision Date
    July 6, 2021
    Product Code
    DYB
    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
    DYB Introducer, Catheter

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    Other Clearances by East End Medical I, LLC

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