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510(k) Data Aggregation

    K Number
    K131998
    Device Name
    ASPIRE RX-LP6 ASPIRATION CATHETER
    Manufacturer
    CONTROL MEDICAL TECHNOLOGY, LLC
    Date Cleared
    2013-11-26

    (151 days)

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

    CONTROL MEDICAL TECHNOLOGY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aspire RX-LP6 Aspiration Catheter and Aspirator are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
    Device Description
    An "Aspire RX-LP6 Aspiration Catheter" includes (1) RX-LP6 Aspiration Catheter and (1) Aspire Aspirator 30ml. - Aspire RX-LP6 Aspiration Catheters (RX-LP6 Aspiration Catheter and Aspire Aspirator): 6F -Guide Cath compatible rapid exchange catheter with 4.8mm long distal aspiration opening, 1.0mm wide distal and 1.1mm wide proximal aspiration lumen, 0.054" outer diameter (OD) single lumen aspiration shaft, and removable stylet. - Aspire Aspirator 30ml. - Aspire RX-LP6 Aspiration Catheters are single-use, sterile, short-term use, and non-pyrogenic medical devices designed for use with piston syringes to remove fresh, soft emboli and thrombi from the peripheral and coronary vasculature. The Aspire RX-LP6 Aspiration Catheter operating and scientific principle is the same as predicate devices. The catheter is inserted into the body over a guidewire and through a sheath or guide catheter to the target anatomy. A syringe is then connected to the catheter and the aspiration is manually created with the syringe. Similar to predicate devices, industry standard intravascular catheter components and materials are used: - -Clear proximal polycarbonate female luer lock, - Stainless steel core wire. - - Clear Main Shafts, - - Embedded platinum iridium radiopaque marker, - - Clear polycarbonate barrel piston syringe. - Aspire RX-LP6 Aspiration Catheters do not add any new materials, or manufacturing processes to the manufacturing process. Same as predicates, all RX-LP6 Aspiration Catheters may be connected to piston syringes including the Aspire Mechanical Aspirator. Aspirators may be connected to other catheters to aspirate fluids and thrombus.
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    K Number
    K113757
    Device Name
    ASPIRE MAX ASPIRATION CATHETER
    Manufacturer
    CONTROL MEDICAL TECHNOLOGY, LLC
    Date Cleared
    2012-02-22

    (63 days)

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

    CONTROL MEDICAL TECHNOLOGY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aspire MAX 5 and MAX 6 Aspiration Catheters and Aspirator are indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
    Device Description
    An Aspire MAX Aspiration Catheter includes (1) Aspire MAX 6 Aspiration Catheter and (1) Aspirator 30ml. Aspire MAX Aspiration Catheters and MAX Aspiration Catheters are single-use, sterile, short-term use, and non-pyrogenic medical devices designed for use with manually operated piston syringes to remove fresh, soft emboli and thrombi from the peripheral and coronary vasculature. The Aspire MAX Aspiration Catheter operating and scientific principle is the same as predicate devices. The catheter is inserted into the body over a guidewire and through a sheath or guide catheter to the target anatomy. A piston syringe is then connected to the catheter and the aspiration is manually created with the piston syringe. Similar to predicate devices, industry standard intravascular catheter components and materials are used: - Clear proximal polycarbonate female luer lock, - -Stainless steel braid, - Clear Pebax and Vestamid Shafts, - - -Embedded platinum iridium radiopaque marker, - Clear polycarbonate barrel piston syringe. - Aspire MAX Aspiration Catheters do not add any new materials, manufacturing processes, colorants, or dyes to the manufacturing process. Same as predicates, all MAX Aspiration Catheters may be connected to piston syringes including the Aspire Aspirator. Aspirators may be connected to other aspiration catheters.
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