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510(k) Data Aggregation

    K Number
    K062275
    Device Name
    RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135
    Manufacturer
    KERBEROS PROXIMAL SOLUTIONS, INC.
    Date Cleared
    2006-09-20

    (44 days)

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

    KERBEROS PROXIMAL SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kerberos Proximal Solutions Rinspiration Catheter System is intended to infuse physician specified fluid and remove/aspirate fresh, soft emboli and thrombi from the coronary and peripheral vasculature.
    Device Description
    The system consists of a Rinspiration® Catheter, and a Rinspirator® with accessories. The Rinspiration Catheter is a multi-lumen, rail configuration catheter that has perforations located near the distal end of the catheter to dispense an infusible fluid. The Rinspiration Catheter will be placed in the vasculature of a patient over a quide wire. The catheter includes a radiopaque marker band at the distal tip and two radiopague marker bands designating the infusion of the catheter. The catheter has a hub on the proximal end that allows access to the infusion and aspiration lumens. The Rinspirator and accessories is a sterile, single-use mechanical device. This hand activated device allows for simultaneous infusion and aspiration of fluids at the treatment site. The device activates two syringes, one for infusion and one for aspiration. This simultaneous infusion and aspiration action is known as "Rinspiration®." The only difference between the cleared Rinspiration System and the Rinspiration Catheter System with Fluid Infusion Stopcock Port is the addition of a 4-way stopcock and a co-extruded paratube that replaces the infusion and aspiration lines. The fluid infusion stopcock port consists of a 4-way stopcock which attaches directly to the infusion check valve. This addition provides the user another means to infuse physician specified fluids. In order to streamline the appearance of the Rinspiration Catheter System, a coextruded paratube replaces the infusion and aspiration lines.
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    K Number
    K050130
    Device Name
    KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM
    Manufacturer
    KERBEROS PROXIMAL SOLUTIONS, INC.
    Date Cleared
    2005-05-13

    (112 days)

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

    KERBEROS PROXIMAL SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kerberos Proximal Solutions Rinspiration System is intended to infuse physician specified fluid and remove/aspirate fluid, fresh, soft emboli and thrombi from the coronary and peripheral vasculature.
    Device Description
    The system consists of a Rinspiration™ Catheter, and a Rinspirator™ with accessories. The Rinspiration Catheter is a multi-lumen, rail configuration catheter that has perforations located near the distal end of the catheter to dispense an infusible fluid. The Rinspiration Catheter will be placed in the vasculature of a patient over a guide wire. The Rinspiration Catheter is offered with a standard tip and a short tip. The catheter includes a radiopaque marker band at the distal tip and two radiopaque marker bands designating the infusion portion of the catheter. The catheter has a hub on the proximal end that allows access to the infusion and aspiration lumens. The Rinspirator and accessories is a sterile, single-use mechanical device. This hand activated device allows for simultaneous infusion and aspiration of fluids at the treatment site. The device activates two syringes, one for infusion and one for aspiration. This simultaneous infusion and aspiration action is known as "Rinspiration."
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    K Number
    K041123
    Device Name
    RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703
    Manufacturer
    KERBEROS PROXIMAL SOLUTIONS, INC.
    Date Cleared
    2004-08-26

    (118 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERBEROS PROXIMAL SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kerberos Proximal Solutions Rinspiration System is intended to infuse and aspirate physician specified fluid in the coronary and peripheral vasculature.
    Device Description
    The system consists of a Rinspiration™ Catheter, and a Rinspirator™ with accessories, The Rinspiration Catheter is a multi-lumen, rail configuration catheter that has perforations located near the distal end of the catheter to dispense an infusible fluid. The Rinspiration Catheter will be placed in the vasculature of a patient over a quide wire. The Rinspiration Catheter is offered with a standard tip and a short tip. The catheter includes a radiopaque marker band at the distal tip and two radiopaque marker bands designating the infusion portion of the catheter. The catheter has a hub on the proximal end that allows access to the infusion and aspiration lumens. The Rinspirator and accessories is a sterile, single-use mechanical device. This hand activated device allows for simultaneous infusion and aspiration of fluids at the treatment site. The device activates two syringes, one for infusion and one for aspiration. This simultaneous infusion and aspiration action is known as "Rinspiration."
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    K Number
    K041151
    Device Name
    KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES
    Manufacturer
    KERBEROS PROXIMAL SOLUTIONS, INC.
    Date Cleared
    2004-07-22

    (80 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERBEROS PROXIMAL SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kerberos Proximal Solutions Occluding Guide Catheter (OCG) and Accessories are intended to facilitate the use and guidance of intravascular catheters into selected blood vessels in the peripheral, cardiovascular and neurovascular systems. The balloon provides temporary vascular occlusion during these percutaneous procedures.
    Device Description
    The Kerberos Proximal Solutions Occluding Guide Catheter (OGC) is a sterile single-use percutaneous catheter consisting of a dual lumen variable stiffness braided shaft catheter incorporating a flush mounted balloon at the distal tip. Guidance and tracking of the catheter through the coronary, neuro or peripheral vasculature is accomplished by torquing of the catheter and/or the use of a guide wire.
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    K Number
    K041291
    Device Name
    RINSPIRATION SYSTEM
    Manufacturer
    KERBEROS PROXIMAL SOLUTIONS, INC.
    Date Cleared
    2004-05-21

    (7 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERBEROS PROXIMAL SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KPS Rinspiration™ System is intended to infuse and aspirate in the peripheral vasculature.
    Device Description
    The system consists of a Rinspiration™ Catheter and a KPS Rinspirator™ with accessories. The KPS Rinspiration™ Catheter is a multi-lumen catheter that has perforations located near the distal end of the catheter to dispense an infusible fluid. The Rinspiration™ Catheter will be placed in the peripheral vasculature of a patient over a quide wire. The catheter has a hub on the proximal end that allows access to the infusion and aspiration lumens. The KPS Rinspirator™ with accessories is a hand activated mechanical device that connects to the hub of the catheter. It allows for simultaneous irrigation and aspiration of the treatment site. The device activates two syringes for infusion and aspiration. This action is known as "Rinspiration™ ,"
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