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510(k) Data Aggregation

    K Number
    K133629
    Device Name
    ANGIOJET ULTRA AVX THROMBECTOMY SET
    Manufacturer
    POSSIS MEDICAL, INC.
    Date Cleared
    2014-02-14

    (80 days)

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

    POSSIS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits ≥ 3 mm in diameter.
    Device Description
    AngioJet Ultra AVX Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra AVX Thrombectomy Set is used with the AngioJet Ultra Console.
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    K Number
    K091593
    Device Name
    ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS
    Manufacturer
    POSSIS MEDICAL, INC.
    Date Cleared
    2009-06-22

    (20 days)

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

    POSSIS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are 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 Ultra DVX and Xpeedior Thrombectomy Sets are sterile, single use, disposable sets that include a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are used with the AngioJet Ultra Console.
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    K Number
    K090253
    Device Name
    ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001
    Manufacturer
    POSSIS MEDICAL, INC.
    Date Cleared
    2009-04-08

    (65 days)

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

    POSSIS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from - . Upper and Lower extremity peripheral arteries > 3 mm in diameter - . Upper extremity peripheral veins > 3 mm in diameter - Ileofemoral and lower extremity veins ≥ 3 mm in diameter . - . AV access conduits > 3 mm 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. The AngioJet Ultra Xpeedior Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from - Upper and Lower extremity peripheral arteries ≥ 3 mm in diameter . - Upper extremity peripheral veins > 3 mm in diameter . - lleofemoral and lower extremity veins > 3 mm in diameter . - . A V access conduits > 3 mm 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 Ultra DVX and Xpeedior Thrombectomy Sets are sterile, single use, disposable sets that include the AngioJet DVX and Xpeedior Thrombectomy catheters and a pump in one combined unit. The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are used with the AngioJet Ultra Console. A 3-port catheter manifold is used, so that contrast media and other fluids can be injected into the bloodstream where the catheter is positioned.
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    K Number
    K082382
    Device Name
    ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
    Manufacturer
    POSSIS MEDICAL, INC.
    Date Cleared
    2008-12-12

    (115 days)

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

    POSSIS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits ≥ 3 mm in diameter.
    Device Description
    Each AngioJet Ultra AVX Thrombectorny Set is a sterile, single use, disposable set that includes the AngioJet AVX Thrombectomy catheter and pump in one combined unit. The AngioJet Ultra AVX Thrombectomy Set is used with the AngioJet Ultra Console. A 3-port catheter manifold is used, so that contrast media and other fluids can be injected into the vascular where the catheter is positioned.
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    K Number
    K081989
    Device Name
    MODIFICATION TO FETCH ASPIRATION CATHETER
    Manufacturer
    POSSIS MEDICAL, INC.
    Date Cleared
    2008-09-26

    (74 days)

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

    POSSIS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fetch Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system and coronary vasculature.
    Device Description
    The FETCH 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 0.052" (1.33 mm) or 4F allows advancement to the target site through a 6F (0.070" I.D.) guiding catheter. A radiopaque marker is located about 2 mm from the distal tip. FETCH is provided with an extension line, 30 cc syringe, one-way stopcock and a 40 micron collection basket. This basket can be used to filter aspirated blood for laboratory analysis of collected thrombus.
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    K Number
    K081454
    Device Name
    GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE
    Manufacturer
    POSSIS MEDICAL, INC.
    Date Cleared
    2008-06-13

    (21 days)

    Product Code
    MJN
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    POSSIS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GuardDOG® Occlusion System is indicated for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids, with or without vessel occlusion. The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature.
    Device Description
    The GuardDOG System consists of two components: An Occlusion Guidewire and a carbon dioxide (CO2) Inflation Device. The GuardDOG Inflation Device is used to inflate the occlusion balloon and seal the guidewire once it is in position.
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    K Number
    K080806
    Device Name
    ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608
    Manufacturer
    POSSIS MEDICAL, INC.
    Date Cleared
    2008-04-04

    (14 days)

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

    POSSIS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AngioJet Ultra Spiroflex VG Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 3 mm in diameter.
    Device Description
    Each AngioJet Ultra Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra Thrombectomy Set is used with the AngioJet Ultra Console.
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    K Number
    K073441
    Device Name
    ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
    Manufacturer
    POSSIS MEDICAL, INC.
    Date Cleared
    2008-01-24

    (48 days)

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

    POSSIS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits > 3.0mm in diameter.
    Device Description
    Each AngioJet Ultra Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra Thrombectomy Set is used with the AngioJet Ultra Console.
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    K Number
    K072769
    Device Name
    ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS
    Manufacturer
    POSSIS MEDICAL, INC.
    Date Cleared
    2007-11-14

    (47 days)

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

    POSSIS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AngioJet Ultra XMI Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries ≥ 2 mm in diameter. The AngioJet Ultra XVG Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 3mm in diameter. The AngioJet Ultra Spiroflex Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 2mm in diameter.
    Device Description
    Each AngioJet Ultra Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra Thrombectomy Set is used with the AngioJet Ultra Console.
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    K Number
    K072269
    Device Name
    ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552
    Manufacturer
    POSSIS MEDICAL, INC.
    Date Cleared
    2007-09-08

    (24 days)

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

    POSSIS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AngioJet Ultra DVX 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 mm in diameter; break apart and remove thrombus from upper extremity and infra-inguinal lower extremity peripheral veins ≥3 mm 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
    Each AngioJet Ultra DVX Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra DVX Thrombectomy Set is used with the AngioJet Ultra Console.
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