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

    SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON

    K Number: K103095 · Decision Oct 22, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    85
    Applicant Total
    7
    Review Days
    14

    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
    SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON
    K Number
    K103095
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic, Ireland
    Date Received
    October 8, 2010
    Decision Date
    October 22, 2010
    Product Code
    LOX
    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
    LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

    Similar 510(k) Clearances

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

    Firefighter™ Pro PTCA Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLASH Flex™ Aorto-Ostial Angioplasty System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ryurei

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sprinter Legend Rapid Exchange Balloon Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Pantera Pro; Pantera LEO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sapphire NC ULTRA Coronary Dilatation Catheter

    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
    K123153 ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT
    K061480 ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM
    K053431 ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM