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

    SafeSept Blunt Needle

    K Number: K210328 · Decision Mar 5, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    50
    Applicant Total
    9
    Review Days
    29

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    Basic Information

    Device Name
    SafeSept Blunt Needle
    K Number
    K210328
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1390
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pressure Products Medical Device Manufacturing, LLC
    Date Received
    February 4, 2021
    Decision Date
    March 5, 2021
    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)
    K181031 TSI Transseptal Introducer
    K172950 TSN Transseptal Needle
    K172934 Needle Free Transseptal Cannula
    K172893 SafeSept Needle Free Transseptal Guidewire
    K170671 SafeSept Transseptal Guidewire