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510(k) Data Aggregation

    K Number
    K172014
    Device Name
    Wedge Microcatheter
    Manufacturer
    Micro Vention, Inc.
    Date Cleared
    2018-04-05

    (276 days)

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

    Micro Vention, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wedge Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and to assist in the delivery of interventional devices, such as the SOFIA 6F Catheter, in the neurovasculature.
    Device Description
    The Wedge Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The microcatheter has a semi-rigid proximal section with an outer shaft made of Grilamid nylon. The catheter shaft transitions to progressively softer durometers and different lengths of Polyether block amide (Pebax). The distal-most length of the microcatheter, beyond the enlarged segment, consists of a softer, atraumatic polyurethane. The enlarged segment on the distal end of the Wedge is designed to reduce the gap between the OD of the guidewire and ID of the Sofia 6F. The tapered bulb section, approximately 1 cm length and located approximately 1.5 cm from the distal tip, can be identified on fluoroscopy between the two radiopaque proximal marker bands of the Wedge Microcatheter. The bulb OD (0.068") is sized specifically to work with the lumen ID (0.070") of the Sofia 6F allowing for continuous flush of saline through the Sofia. Three radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the microcatheter is coated with a hydrophilic polymer coating to reduce friction during navigation in the vasculature. The lubricious inner liner is made from polytetrafluoroethylene (PTFE). A luer fitting on the Microcatheter hub is used for the attachment of accessories. The hub/strain relief provides for the kink resistance at the proximal end. The microcatheter has a straight tip that is designed to be steam shaped by the physicians at the time of the use. A steam shaping mandrel and introducer sheath (accessories) are packaged with the catheter.
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    K Number
    K151358
    Device Name
    AZUR CX Detachable 35 Coils
    Manufacturer
    Micro Vention, Inc.
    Date Cleared
    2015-09-25

    (128 days)

    Product Code
    KRD
    Regulation Number
    870.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Micro Vention, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AZUR Peripheral Coil System is intended to reduce or blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.
    Device Description
    The AZUR CX Coils consist of implant coil made of platinum alloy with inner hydrogel core. The coils are designed in 3D spherical structure in various loop sizes and lengths. The AZUR CX Coil System (Detachable) consists of an implantable coil attached to a delivery pusher. The coil system is delivered to the treatment site through the microcatheter. The proximal end of the delivery pusher is inserted to the AZUR detachment controller. The detachment controller is activated by the user and this detaches the coil. The AZUR coils are designed for use with the AZUR Detachment Controller (Also known as AZUR Detachment Controller), specifically designed for coil detachment and is sold separately.
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    K Number
    K142449
    Device Name
    Headway 27 Microcatheter
    Manufacturer
    MICRO VENTION, INC.
    Date Cleared
    2015-03-26

    (205 days)

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

    MICRO VENTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.
    Device Description
    The Headway 27 Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. An introducer sheath and shaping mandrel are also provided.
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    K Number
    K131482
    Device Name
    SOFIA DISTAL ACCESS CATHETER
    Manufacturer
    MICRO VENTION, INC.
    Date Cleared
    2013-11-22

    (183 days)

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

    MICRO VENTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SOFIA Distal Access Catheter is intended for general intravascular use, including The GOT IA Dicture al vasculature. It can be used to facilitate the introduction of the nours and therapeutic agents. It is not intended for use in coronary arteries.
    Device Description
    The SOFIA Distal Access Catheter is a single-lumen, flexible catheter designed with coil and braid reinforcement. The distal segment is steam-shapeable and it has a hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. An introducer sheath and shaping mandrel are also provided.
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    K Number
    K132083
    Device Name
    AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35
    Manufacturer
    MICRO VENTION, INC.
    Date Cleared
    2013-10-28

    (115 days)

    Product Code
    KRD
    Regulation Number
    870.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO VENTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AZUR PURE is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.
    Device Description
    The AZUR PURE Peripheral Coil System, Pushable 35, consists of an implantable all-polymer coil housed in an introducer. A stainless steel stylet is used to deploy the coil from the introducer into a delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire.
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    K Number
    K121785
    Device Name
    SCEPTER C OCCLUSION BALLOON CATHETER
    Manufacturer
    MICRO VENTION, INC.
    Date Cleared
    2012-08-10

    (53 days)

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

    MICRO VENTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in the blood vessels of the peripheral and neurovasculature where temporary occlusion is desired. These catheters offer a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow and for balloon assisted embolization of intracranial aneurysms. For use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials. For neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials, that have been approved or cleared for use in the neurovasculature and are compatible with the inner diameter of the Scepter C/XC Balloon Catheter.
    Device Description
    The Scepter C and XC Occlusion Balloon Catheter is a dual coaxial lumen catheter with a nondetachable low inflation pressure compliant balloon attached to the distal end of the catheter. The catheter is designed to track over a steerable guidewire. The inner lumen can be used for infusion/delivery of diagnostic and therapeutic agents. The outer lumen is used for the inflation and deflation of the balloon independent of guidewire position. Radiopaque marker bands are located at ends of the balloon and distal tip of the catheter to facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the microcatheter hub is used for the attachment of accessories. The catheters are packaged sterile for single use only.
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    K Number
    K120630
    Device Name
    AZUR DETACHABLE 18
    Manufacturer
    MICRO VENTION, INC.
    Date Cleared
    2012-03-28

    (27 days)

    Product Code
    KRD
    Regulation Number
    870.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO VENTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AZUR Peripheral Coil System is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.
    Device Description
    The AZUR Peripheral Coil System - Detachable 18 Coils are designed in the helical structure in various diameter and lengths. The coils are comprised of platinum alloy that are wound around the mandrels to form into the helical shape. The implant segment is then attached to the delivery pusher. The pusher is inserted into detachment controller which when activated detaches the coil from the delivery pusher. The detachment controller utilizes battery power to detach the coils from the delivery pusher. The coils are specified to be delivered through a microcatheter with a minimum inner diameter of 0.021" (0.053 mm).
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    K Number
    K113698
    Device Name
    SCEPTER XC OCCLUSION BALLOON CATHETER
    Manufacturer
    MICRO VENTION, INC.
    Date Cleared
    2012-01-13

    (28 days)

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

    MICRO VENTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scepter XC Occlusion Balloon Catheter is intended for use in the peripheral and neurovasculature where temporary occlusion is desired. The balloon catheter provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheter also offers balloon assisted embolization of intracranial aneurysms.
    Device Description
    The Scepter XC Occlusion Batheter is a dual coaxial lumen catheter with a nondetachable low inflation pressure compliant balloon attached to the distal end of the catheter. The catheter is designed to track over a steerable guidewire. Radiopaque marker bands are located at ends of the balloon and distal tip of the catheter to facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the microcatheter hub is used for the attachment of accessories. The catheters are packaged sterile for single use only.
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    K Number
    K110813
    Device Name
    HEADWAY 27 MICROCATHETER
    Manufacturer
    MICRO VENTION, INC.
    Date Cleared
    2011-08-05

    (134 days)

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

    MICRO VENTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Headway 27 Microcatheter is intended for general intravascular use, including the peripheral, coronary and neurovasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.
    Device Description
    The Headway 27 Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the Microcatheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the Microcatheter hub is used for the attachment of accessories.
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