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510(k) Data Aggregation

    K Number
    K162625
    Device Name
    SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters
    Date Cleared
    2017-06-12

    (265 days)

    Product Code
    Regulation Number
    870.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    B. BRAUN INTERVENTIONAL SYSTEMS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SeQuent® Neo PTCA Dilatation Catheters are indicated for the balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon sizes 2.00-4.00mm are also indicated for post-delivery expansion of balloon expandable stents.
    Device Description
    The SeQuent® Neo PTCA-Catheter is a balloon-tipped, rapid exchange catheter. The distal shaft (25 cm) consists of two (2) lumina. One lumen enables inflation and deflation of the balloon, the other permits the insertion of a guidewire. Two (2) radiopaque markers indicate the length of the cylindrical portion of the balloon. The 1.5 mm diameter balloon catheter has one (1) x-ray marker only. The balloon is protected with a removable sheath which protects the initial profile. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The two markers on the shaft of the catheter appear when the tip of the balloon-tipped catheter leaves the guiding catheter (brachial: 100 cm/femoral: 110 cm). The proximal section of the catheter is a single-lumen, stainless steel hypotube with a luer adapter connected to the balloon lumen. A needle with a luer port is included for flushing the distal guide wire lumen. SeQuent Neo has a hydrophilic coated surface at the distal catheter portion. Due to this, SeQuent Neo provides optimal gliding properties during intervention.
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    K Number
    K130576
    Device Name
    CELSITE IMPLANTABLE ACCESS PORT SYSTEMS
    Date Cleared
    2013-04-02

    (28 days)

    Product Code
    Regulation Number
    880.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    B. BRAUN INTERVENTIONAL SYSTEMS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Celsite Access Ports are indicated for patient therapies requiring repeated access to the vascular system. - Celsite / Celsite Concept Access Ports are indicated for intra-venous administration of drugs for chemotherapy, antibiotics and anti-viral drugs, and for parenteral nutrition, blood sampling or transfusions. - Celsite Discreet / Celsite Dual Venous / Celsite Brachial / Celsite Babyport / Celsite Babyport S Ports are recommended for use whenever patient therapy requires repeated I.V. Access for injection, drug therapy and/or blood sampling.
    Device Description
    The Celsite® Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medication and fluids. The Celsite system consists of an access port with a silicone septum, which is connected to a catheter using a connection ring. The triangular shaped access port has a low profile nose, finger stops on the side of the housing, and a round base. Celsite access ports have suture holes or suture zones to secure placement during implantation. Celsite family infusion port product lines include: Celsite Discreet, and Celsite Concept. Celsite product lines are offered in 'standard' or 'small' sizes. - Celsite Access ports are manufactured with a low-profile design with titanium / polysulphone or titanium / epoxy materials. Catheters are available in either polyurethane or silicone materials. Some Celsite ports are available with pre-connected catheters. - Celsite Discreet ports are manufactured with a low-profile design with a left or right off-set exit cannula that permits a vertical incision and a 90 degree port/exit cannula. Celsite Discreet ports are manufactured with titanium / epoxy materials. Catheters are available in either polyurethane or silicone materials. - Celsite Concept ports are manufactured with a low-profile, light weight design and have three silicone suture areas, which provide the physician with flexibility in suturing. Celsite Concept ports are manufactured with titanium / polysulphone / silicone materials. Catheters are available in either polyurethane or silicone materials.
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