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    K Number
    K101354
    Device Name
    FETCH 2 ASPIRATION CATHETER MODEL 109400-001
    Manufacturer
    MEDRAD INTERVENTIONAL/POSSIS
    Date Cleared
    2011-01-21

    (252 days)

    Product Code
    QEZ, DXE, OEZ
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDRAD INTERVENTIONAL/POSSIS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
    Device Description
    The Fetch 2 Aspiration Catheter is a rapid exchange, low-profile tip, dual lumen catheter that uses a 0.014" (0.36 mm) guide wire to track to the target site. It is used for aspiration of fresh, soft emboli and thrombi. Its outer diameter (0.056" or 4F) allows advancement to the target site through a 6F (0.070" I.D.) guiding catheter. A radiopaque marker is located near the distal tip. Fetch 2 is provided with an extension line (connected to a one-way stopcock), 2 - 30 cc syringes, and 2 - 40 micron collection baskets. The baskets can be used to filter aspirated blood for laboratory analysis of collected thrombus.
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    K Number
    K101406
    Device Name
    ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001
    Manufacturer
    MEDRAD INTERVENTIONAL/POSSIS
    Date Cleared
    2010-06-16

    (28 days)

    Product Code
    QEZ, DXE, KRA
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDRAD INTERVENTIONAL/POSSIS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AngioJet Solent Proxi Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from : - upper and lower extremity peripheral arteries ≥ 3.0mm in diameter, . - upper extremity peripheral veins ≥ 3.0mm in diameter, . - ileofemoral and lower extremity veins ≥ 3.0mm in diameter, . - A-V access conduits ≥ 3.0mm in diameter and . - for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of . physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
    Device Description
    AngioJet Solent Proxi Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Solent Proxi Thrombectomy Set is used with the AngioJet Ultra Console.
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