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510(k) Data Aggregation

    K Number
    K203840
    Device Name
    BOSS 8F Balloon Guide Catheter
    Manufacturer
    Marblehead Medical LLC
    Date Cleared
    2021-01-28

    (28 days)

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

    Marblehead Medical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BOSS™ 8F Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these procedures. The balloon guide catheter is also indicated for use as a conduit for retrieval devices.
    Device Description
    The BOSS 8F Balloon Guide Catheter system is a sterile, single-use intravascular catheter. The BOSS 8F Balloon Guide Catheter is an 85 and 95 cm long, variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and a radiopaque marker band at the tip distal to the balloon. The catheter shaft has an annular inflation lumen and a coaxial central lumen with stainless steel coil and is braid reinforced. The hub central port leads to the central lumen to facilitate introduction of interventional devices through the central lumen. The inflation port is positioned at an angle to the central port, connecting to the annular inflation lumen, and is used to facilitate inflating and deflating the balloon with a syringe. The BOSS 8F Balloon Guide Catheter uses a distal hydrophilic coating to provide lubricity and reduce friction between the catheter shaft and the vessel wall. The BOSS 8F Balloon Guide Catheter is packaged with the 6F dilator to facilitate the option of direct access into the blood vessel without the use of an introducer sheath.
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    K Number
    K200910
    Device Name
    BOSS Balloon Guide Catheter
    Manufacturer
    Marblehead Medical
    Date Cleared
    2020-05-02

    (26 days)

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

    Marblehead Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BOSS Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these procedures. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.
    Device Description
    The BOSS Balloon Guide Catheter system is a sterile, single-use intravascular catheter. The BOSS Balloon Guide Catheter is a 90 cm long, variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and a radiopaque marker band at the tip distal to the balloon. The catheter shaft has an annular inflation lumen and a coaxial central lumen with stainless steel coil and is braid reinforced. The hub central port leads to the central lumen to facilitate introduction of interventional devices through the central lumen. The inflation port is positioned at an angle to the central port, connecting to the annular inflation lumen, and is used to facilitate inflating and deflating the balloon with a syringe. The BOSS Balloon Guide Catheter uses a distal hydrophilic coating to provide lubricity and reduce friction between the catheter shaft and the vessel wall. The BOSS Balloon Guide Catheter is packaged with the 6F dilator to facilitate the option of direct access into the blood vessel without the use of an introducer sheath.
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