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

    TXM Guiding Sheath

    K Number: K153771 · Decision Sep 13, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    7
    Review Days
    258

    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
    TXM Guiding Sheath
    K Number
    K153771
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Texasmedical Technologies, Inc.
    Date Received
    December 30, 2015
    Decision Date
    September 13, 2016
    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

    Similar 510(k) Clearances

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

    FieldFlex Steerable Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Echo Large Bore Introducer Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Introducer Sheath Set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Edwards eSheath+ introducer set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Aventus Introducer Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Protaryx Transseptal Puncture Device (PTX2-001)

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

    Other Clearances by Texasmedical Technologies, Inc.

    K Number Device Name
    K170915 TXM Hydrophilic Guidewire
    K170914 TXM Support Catheter
    K153703 Guiding Catheter
    K153125 IntraNovo Microcatheter
    K142954 PTA 14 Balloon Dilatation Catheter OTW
    K142817 IntraNovo 25 Microcatheter