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510(k) Data Aggregation

    K Number
    K023870
    Device Name
    FLEXIMA BILIARY CATHETER
    Manufacturer
    BOSTON SCIENTIFIC/MEDI-TECH
    Date Cleared
    2002-12-20

    (30 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOSTON SCIENTIFIC/MEDI-TECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flexima Biliary Catheter is designed for external and internal percutaneous drainage of the biliary system.
    Device Description
    The Flexima Biliary Catheter is designed for external and internal percutaneous drainage of the biliary system. The major components of the Flexima Biliary Catheter are the drainage catheter, metal stiffening cannula, flexible stiffening cannula and luer cap.
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    K Number
    K020012
    Device Name
    MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER
    Manufacturer
    BOSTON SCIENTIFIC/MEDI-TECH
    Date Cleared
    2002-01-29

    (26 days)

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

    BOSTON SCIENTIFIC/MEDI-TECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Renegade™ Fiber Braided Microcatheters are intended for general intravascular use, including neuro, peripheral and coronary vasculature. The catheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.
    Device Description
    The Renegade™ Fiber Braided Microcatheters are intended for general intravascular use, including neuro, peripheral and coronary vasculature. The catheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.
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    K Number
    K012948
    Device Name
    MODIFICATION TO VAXCEL DIALYSIS CATHETER
    Manufacturer
    BOSTON SCIENTIFIC/MEDI-TECH
    Date Cleared
    2001-10-03

    (29 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOSTON SCIENTIFIC/MEDI-TECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vaxcel™ Dialysis Catheter is designed for chronic hemodialysis and apheresis.
    Device Description
    The major components of the Vaxcel™ Dialysis Catheter are the dual lumen catheter, hub, injection cap, introducer sheath/dilator and metal tunneler with protective sheath.
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    K Number
    K012952
    Device Name
    HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT
    Manufacturer
    BOSTON SCIENTIFIC/MEDI-TECH
    Date Cleared
    2001-10-02

    (28 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOSTON SCIENTIFIC/MEDI-TECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hemashield Gold ™ Woven Double Velour Vascular Graft is indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
    Device Description
    The Branch Graft Configurations is different from the rest of the Hemashield Gold Woven Double Velour Vascular Graft product line only in the 1-4 branch configuration in which the grafts are sewn. The modified vascular grafts have the following similarities to those which previously received 510(k) concurrence: Identical indications for use, Identical labeling, Identical manufacturing processes, Identical operating principle, Incorporate identical materials, Have the identical shelf-life (5 years), Are packaged and sterilized using identical packaging materials and processes.
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    K Number
    K011664
    Device Name
    IMAGER II ANGIOGRAPHIC CATHETER
    Manufacturer
    BOSTON SCIENTIFIC/MEDI-TECH
    Date Cleared
    2001-09-07

    (100 days)

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

    BOSTON SCIENTIFIC/MEDI-TECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMAGER™II Angiographic Catheters are indicated for use to provide a pathway for delivering contrast media to selected sites in the vascular system.
    Device Description
    The IMAGER™II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system. The IMAGER™II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters and are available in a variety of flush and selective shapes with lengths of 40 cm, 65 cm, 90cm and 100 cm. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy.
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