BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT

    K Number: K123153 · Decision Apr 9, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    7
    Review Days
    182

    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
    ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT
    K Number
    K123153
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic, Ireland
    Date Received
    October 9, 2012
    Decision Date
    April 9, 2013
    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 Medtronic, Ireland

    K Number Device Name
    K251970 Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
    K252390 Telescope Guide Extension Catheter
    K250787 Liberant Thrombectomy System
    K103095 SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON
    K061480 ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM
    K053431 ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM