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510(k) Data Aggregation

    K Number
    K143398
    Device Name
    Plato MICROCATH 27B Microcatheter
    Manufacturer
    SCIENTIA VASCULAR , LLC
    Date Cleared
    2015-06-26

    (212 days)

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

    SCIENTIA VASCULAR , LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Plato MICROCATH 27B Microcatheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents to the peripheral system. The cather is not intended for use in cither the coronary or neuro vasculature.
    Device Description
    The Plato MICROCATH® 27B Microcatheter is a single lumen microcatheter constructed with a flexible polymer shaft of varying stiffness to aide in accessing vasculature. The catheter is designed to be used with a guide catheter and a steerable guidewire for accessing the vasculature. The proximal end of the catheter has a diameter of 3.4F, tapering to a distal OD of 3.2F, which can be inserted into a 5F guide catheter. The inner diameter is constant throughout the shaft length and accommodates up to a 0.025" guidewire. The catheter is 150 cm in length with a straight tip configuration which can be steam-shaped to the doctor's preferred shape. A steam shaping mandrel is included in the packaging. The microcatheter has hydrophilic coating on the outer distal shaft to reduce friction during manipulation in vessels and has one radiopaque tip marker to facilitate fluoroscopic visualization.
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    K Number
    K121734
    Device Name
    PLATO MICROCATH 27 MICROCATHETER
    Manufacturer
    SCIENTIA VASCULAR , LLC
    Date Cleared
    2012-07-30

    (47 days)

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

    SCIENTIA VASCULAR , LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Plato MICROCATH® 27 Microcatheters are intended to assist in the delivery of diagnostic and/or therapeutic agents to the peripheral and neurovascular systems.
    Device Description
    The Plato MICROCATH® 27 Microcatheters are single lumen catheters designed to be used with a guiding catheter and a steerable guidewire for accessing the vasculature. The microcatheter contains a metal hypotube reinforced shaft with a maximum diameter of 3.7F, tapering to a distal end of 3.3F, which can be inserted into a 6F guide catheter. The inner diameter is constant throughout the shaft length and accommodates up to a 0.025" guidewire. The catheter is 150 cm in length with two tip configurations; straight and 45°. All have steam shapeable tips, hydrophilic coating and a radiopaque marker at the distal tip. The devices are marketed with an accessory mandrel which allows the catheter tips to be steam-shaped to the doctor's preferred shape when desired.
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