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

    SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)

    K Number: K253799 · Decision Mar 13, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    19
    Applicant Total
    9
    Review Days
    105

    Basic Information

    Device Name
    SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)
    K Number
    K253799
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5175
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pressure Products Medical Device Manufacturing, LLC
    Date Received
    November 28, 2025
    Decision Date
    March 13, 2026
    Product Code
    DXF
    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
    DXF Catheter, Septostomy

    Similar 510(k) Clearances

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

    HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cross Wise™ Multi-Use RF Adapter Cable

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VersaCross™ RF Wire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)

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

    Other Clearances by Pressure Products Medical Device Manufacturing, LLC

    K Number Device Name
    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
    K170671 SafeSept Transseptal Guidewire