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510(k) Data Aggregation

    K Number
    K991898
    Device Name
    ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE
    Manufacturer
    MICROVENA CORP.
    Date Cleared
    1999-06-16

    (12 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROVENA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 0.035" and 0.025" Hytek guidewire is indicated for use in the peripheral vasculature. The 0.014". 0.016", and 0.018" HyTek Guidewires are indicated for use in the peripheral and coronary vasculature.
    Device Description
    The MICROVENA HyTek Guidewire is designed to fit inside a catheter, for the purpose of directing the catheter through a blood vessel. The main body of the guidewire is constructed of Nitinol. The distal tip is a helical coiled wire wound around the inner core. The guidewire is coated with a hydrophilic coating to help facilitate smoother passage. The HyTek Guidewire is available in diameters of .014" to .035, and in lengths from 80 cm to 300 cm.
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    K Number
    K991194
    Device Name
    MODIFICATION TO ULTRA-SELECT GUIDEWIRE
    Manufacturer
    MICROVENA CORP.
    Date Cleared
    1999-05-05

    (27 days)

    Product Code
    DQX, DOX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROVENA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 0.025" HyTek guidewire is indicated for use in the peripheral vasculature. The 0.014". 0.016", and 0.018" HyTek Guidewires are indicated for use in the peripheral and coronary vasculature.
    Device Description
    The MICROVENA HyTek Guidewire is designed to fit inside a catheter, for directing the catheter through a blood vessel. The main body of the guidewire is constructed of Nitinol. The distal tip is a helical coiled wire wound around the inner core. The guidewire is coated with a hydrophilic coating to facilitate smoother passage. The HyTek Guidewire is available in diameters of .014" to .025, and in lengths from 80 cm to 300 cm.
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    K Number
    K982657
    Device Name
    AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100
    Manufacturer
    MICROVENA CORP.
    Date Cleared
    1998-11-18

    (111 days)

    Product Code
    MCW
    Regulation Number
    870.4875
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROVENA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Amplatz Thrombectomy Device (ATD) is intended for use in the mechanical dissolution of acute and subacute thrombus within dialysis fistulae.
    Device Description
    The Amplatz Thrombectomy Device (ATD) is a percutaneous, thrombectomy device consisting of a catheter, a small diameter impeller encased in a distal housing, and a driveshaft. The driveshaft is the connection between the impeller and a disposable, high speed, air driven motor. An infusion line with luer connector, attached to the proximal motor housing, allows infusion of saline. A foot pedal/regulator assembly is required to operate the air motor.
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    K Number
    K970668
    Device Name
    THE AMPLANTZ GOOSE NECK MICROSNARE
    Manufacturer
    MICROVENA CORP.
    Date Cleared
    1998-06-10

    (471 days)

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

    MICROVENA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Amplatz "GOOSE NECK" Microsnare is intended for use as a tool to retrieve and manipulate foreign bodies from distal peripheral vessels of the cardiovascular system and hollow viscus. This includes intravascular foreign objects such as coils, balloons, portions of catheter and/or guidewires misplaced during interventional radiological procedures within the peripheral, neuro and cardiovasculature. The Amplatz Goose Neck MicroSnare (NEUROSnare) is intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the cornary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.
    Device Description
    The Amplatz "GOOSE NECK" Microsnare is a percutaneous retrieval and manipulation device with a uniquely shaped retriever loop. The "GOOSE NECK" Microsnare component consists of a core wire, with the "beak-like" retriever loop mounted at a right angle to the axis of shaft at its distal tip. The device is primarily comprised of a nickel-titanium alloy allowing virtual kink-resistant performance during navigation and retrieval of a foreign object.
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    K Number
    K972511
    Device Name
    AMPLATZ GOOSE NECK SNARE KIT/ CATHETER
    Manufacturer
    MICROVENA CORP.
    Date Cleared
    1998-03-06

    (246 days)

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

    MICROVENA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Amplatz Goose Neck Snare is a Class II device intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access venipuncture procedure assistance.
    Device Description
    The Amplatz Goose Neck Snare consists of a braided nitinol loop attached to a solid core nitinol guidewire. The plane of the loop is perpendicular to the host wire. The loop is covered with a gold-plated tungsten coil to enhance radiopaque. The shaft of the snare consists of a solid continuous Nitinol core wire shaft. The loop snare is delivered in a multi-purpose catheter. The catheter has a radiopaque marker band at its distal tip. The package configuration consists of a compact spiral configuration, using hoops to contain the snare and catheter. These spiral hoops are then double pouched in Tyvek/mylar pouches.
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    K Number
    K971984
    Device Name
    AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)
    Manufacturer
    MICROVENA CORP.
    Date Cleared
    1997-09-19

    (113 days)

    Product Code
    MCW
    Regulation Number
    870.4875
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROVENA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The modified Amplatz Thrombectomy Device (ATD) is intended for use in the mechanical dissolution of acute and sub-acute thrombus within dialysis fistulae.
    Device Description
    The Amplatz Thrombectomy Device (ATD) is a percutaneous, rotational thrombectomy device consisting of a polyurethane catheter. Inside the catheter, a distal rotor housing contains a small diameter, recessed impeller, attached to a drive shaft. The shaft is connected to a disposable, high speed, air driven motor. An infusion line with luer connector, attached to the proximal motor assembly, allows for infusion of saline through the catheter. A foot pedal/regulator assembly is required to operate the air motor.
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    K Number
    K954642
    Device Name
    HYDRO-SELECT GUIDEWIRE
    Manufacturer
    MICROVENA CORP.
    Date Cleared
    1996-12-17

    (434 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROVENA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HyTek Guidewire is intended for general intravascular use to aid in the selective placement of catheters in the coronary and peripheral and visceral vasculature during diagnostic and/or therapeutic procedures.
    Device Description
    The shaft of the HyTek Guidewire is constructed of Nitinol (nickel titanium alloy). The Nitinol core is a continuous piece of wire extending from the distal tip to the proximal shaft. The distal tip is tapered to provide flexibility and softness. The distal tip is composed of gold plated tungsten wire. The guidewire is coated with a hydrophilic coating to enhance lubricity.
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    K Number
    K954205
    Device Name
    THE AMPLATZ THROMBECTOMY DEVICE
    Manufacturer
    MICROVENA CORP.
    Date Cleared
    1996-08-13

    (341 days)

    Product Code
    MCW
    Regulation Number
    870.4875
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROVENA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Amplatz Thrombectomy Device is intended for mechanical dissolution of acute and subacute thrombus in dialysis fistulae. This device is not intended to be used for the removal of atheroma and is contraindicated in coronary, cerebral, and pulmonary vessels.
    Device Description
    The Amplatz Thrombectomy Device is a polyurethane catheter that contains a distal rotor housing in which a small diameter, recessed impeller is attached to a drive shaft. The shaft is connected to a disposable, high-speed air-driven motor. An infusion line with luer connector, attached to the proximal casing, allows infusion of saline, contrast medium, or thrombolytic medications.
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    K Number
    K955304
    Device Name
    CRICKET
    Manufacturer
    MICROVENA CORP.
    Date Cleared
    1996-05-16

    (178 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROVENA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CRICKET™ is intended to be used as a steering mechanism for guidewires. The opposite end of the CRICKET™ has a shaping bar which allows for shaping the distal tip of guidewires (revised February 13, 1996)
    Device Description
    The CRICKET™ is intended to be used as a steering mechanism for guidewires. The opposite end of the CRICKET™ has a shaping bar which allows for shaping the distal tip of guidewires (revised February 13, 1996)
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