Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K233420
    Device Name
    Axium Detachable Coil; Axium Prime Detachable Coil
    Manufacturer
    Micro Therapeutics, lnc. d/b/a ev3 Neurovascular
    Date Cleared
    2023-11-07

    (28 days)

    Product Code
    HCG, KRD
    Regulation Number
    882.5950
    Why did this record match?
    Applicant Name (Manufacturer) :

    Micro Therapeutics, lnc. d/b/a ev3 Neurovascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Axium™ Detachable Coil: Axium™ Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. Axium™ Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. Axium™ Prime Detachable Coil: (Models: APB-X-Y-3D-ES, APB-X-Y-3D-SS, APB-X-Y-HX-ES, APB-X-Y-HX-SS) The Axium™ Prime Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. The Axium™ Prime Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. Axium™ Prime Detachable Coil: (Models: FC-X-Y-3D) The Axium™ Prime Detachable Col is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium™ Prime Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.
    Device Description
    The Axium™ Detachable Coil and Axium™ Prime Detachable Coil consist of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held Instant Detacher (I.D.) which when activated detaches the coil from the delivery pusher tip. The I.D. is sold separately.
    Ask a Question
    K Number
    K210230
    Device Name
    Phenom Catheters
    Manufacturer
    Micro Therapeutics, lnc. d/b/a ev3 Neurovascular
    Date Cleared
    2021-02-25

    (28 days)

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

    Micro Therapeutics, lnc. d/b/a ev3 Neurovascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Phenom™ Catheters are intended for the introduction of interventional devices or diagnostic agents into the neuro, peripheral, and coronary vasculatures.
    Device Description
    The Phenom™ Catheters are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. They are available in a variety of lengths, stiffness and inner and outer diameters. The outer surface of the catheter is coated to enhance navigation in the vessel. The Phenom™ 17, 21, and 27 Catheters have a hydrophilic coating that spans the distal 100cm. The Phenom™ Plus Catheters have a hydrophilic coating that spans the distal 90cm. The catheter also incorporates a liner to facilitate movement of introduction devices passing through its lumen. The distal tip has radiopaque marker(s) to aid visualization and positioning under fluoroscopy. The Phenom™ Catheter is packaged with a shaping mandrel and may be accompanied with a split introducer sheath.
    Ask a Question

    Page 1 of 1