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

    SafeSept Transseptal Guidewire

    K Number: K170671 · Decision Oct 20, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    50
    Applicant Total
    9
    Review Days
    228

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    Basic Information

    Device Name
    SafeSept Transseptal Guidewire
    K Number
    K170671
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1390
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pressure Products Medical Device Manufacturing, LLC
    Date Received
    March 6, 2017
    Decision Date
    October 20, 2017
    Product Code
    DRC
    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
    DRC Trocar

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    Other Clearances by Pressure Products Medical Device Manufacturing, LLC

    K Number Device Name
    K253799 SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)
    K241042 SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
    K221707 SafeSept® Transseptal Guidewire (SS-140)
    K210328 SafeSept Blunt Needle
    K181031 TSI Transseptal Introducer
    K172950 TSN Transseptal Needle
    K172934 Needle Free Transseptal Cannula
    K172893 SafeSept Needle Free Transseptal Guidewire