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

    REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM

    K Number: K102418 · Decision Apr 15, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    10
    Review Days
    233

    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
    REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM
    K Number
    K102418
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Reverse Medical Corporation
    Date Received
    August 25, 2010
    Decision Date
    April 15, 2011
    Product Code
    DQY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    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 Reverse Medical Corporation

    K Number Device Name
    K150108 Reverse Medical Micro Vascular Plug System
    K141313 REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM
    K133282 REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
    K130858 REVERSE MEDICAL MICROCATHETER
    K123803 REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
    K122684 REVERSE MEDICAL MICROCATHETER
    K112262 REFLEX BALLON GUIDE CATHETER
    K110055 REVERSE MEDICAL REFLEX GUIDE CATHETER
    K091563 RECRUIT MICROCATHETER