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

    AMPLATZER RELIANT CATHETER DELIVERY SYSTEM

    K Number: K070238 · Decision Feb 28, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    14
    Review Days
    34

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    Basic Information

    Device Name
    AMPLATZER RELIANT CATHETER DELIVERY SYSTEM
    K Number
    K070238
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aga Medical Corp.
    Date Received
    January 25, 2007
    Decision Date
    February 28, 2007
    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

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    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
    K080757 AMPLATZER TORQVUE LOW PROFILE DELIVERY 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
    K053187 AMPLATZER NOODLEWIRE GUIDEWIRE
    Search all 14 clearances from Aga Medical Corp. →