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

    Guiding Catheter

    K Number: K153703 · Decision May 12, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    7
    Review Days
    141

    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
    Guiding Catheter
    K Number
    K153703
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Texasmedical Technologies, Inc.
    Date Received
    December 23, 2015
    Decision Date
    May 12, 2016
    Product Code
    DQY
    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
    DQY Catheter, Percutaneous

    Similar 510(k) Clearances

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

    Amplatzer TorqVue Exchange System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Perfect-O Ostial Positioning Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Amplatzer TorqVue Delivery System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Teleport Glide Microcatheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)

    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
    K153771 TXM Guiding Sheath
    K153125 IntraNovo Microcatheter
    K142954 PTA 14 Balloon Dilatation Catheter OTW
    K142817 IntraNovo 25 Microcatheter