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

    AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM

    K Number: K080757 · Decision Apr 18, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    14
    Review Days
    31

    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
    AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM
    K Number
    K080757
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aga Medical Corp.
    Date Received
    March 18, 2008
    Decision Date
    April 18, 2008
    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 Aga Medical Corp.

    K Number Device Name
    K113658 AMPLATZER VASCULAR PLUG 4
    K093476 AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120
    K091793 AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54
    K083214 AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100
    K080994 AMPLATZER TORQVUE EXCHANGE SYSTEM
    K072313 AMPLATZER TORQVUE DELIVERY SYSTEM
    K071699 AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022
    K071125 AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016
    K070238 AMPLATZER RELIANT CATHETER DELIVERY SYSTEM
    K053187 AMPLATZER NOODLEWIRE GUIDEWIRE
    Search all 14 clearances from Aga Medical Corp. →