Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K221245
    Device Name
    PTA Balloon Dilatation Catheter
    Date Cleared
    2022-12-14

    (226 days)

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

    Kossel Medtech (Suzhou) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PTA balloon dilatation catheter is indicated for the percutaneous transluminal angioplasty (PTA) of the peripheral vascular system, including the iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
    Device Description
    The 0.0180" PTA balloon dilatation catheter is mainly composed of tip tube, inner tube, balloon, marker bands, outer tube, stress release tube and hub. Among them the balloon is the most important part of the catheter. In order to dilate different stenosis, the balloon should be dilated to difference dimension by inflating different pressure. The soft tip at the end of the balloon is to make the balloon catheter more easily to push to the stenosis position. The inner tubing which connects to the tip tubing is for guide wire passage and the pushing road. The two marker bands which wrapping on the inner tubing are for positioning the balloon location by cooperating in vitro monitoring equipment. The distal of the outer tube is connected with the balloon by a variable-diameter stretching structure, which can make the balloon get smaller winding diameter. The proximal of the outer tube is connected with the hub as the inflation passage and the pushing shaft. The hub is for connecting the outer pressure filling equipment. The stress release tubing is for protecting the outer tube from bending. The outer surface of the catheter is coated with a hydrophilic coating that ranges 400mm in length from the tip tube to the proximal end of the balloon, including part of the outer tube.
    Ask a Question

    Ask a specific question about this device

    K Number
    K211349
    Device Name
    Selebrek PTCA Balloon Dilatation Catheter
    Date Cleared
    2022-01-07

    (249 days)

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

    Kossel Medtech (Suzhou) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Selebrek PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
    Device Description
    The Selebrek PTCA Balloon Dilatation Catheter is a rapid exchange (RX) PTCA Balloon Dilatation Catheter used for the purpose of dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Selebrek is a sterile, single-use, intravascular medical device with a working length of 142cm. The proximal shaft is PTFE coated stainless steel tube, which allows for exceptional push ability and a smooth transition to the distal shaft, which is composed of an outer tube, an inner tube, and a balloon. A hydrophilic coating is applied to the distal section. The semicompliant balloons are available in diameters of 1.5mm and lengths from 6-30mm, and have a rated burst pressure of 14 atm. The proximal shaft of the catheter has two marker sections of 5mm length that aid in gauging dilatation catheter position relative to the guiding catheter located closest to the dilatation catheter adaptor is for femoral guiding catheters and the other marker is for brachial guiding catheters). The distal shaft of the catheter has an integrated shaft system. The shaft has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The other lumen, in the distal shaft, permits the use of a quide wire to facilitate advancement of the dilatation catheter to and through the stenosis to be dilated. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial quidance and rapid exchange of the catheter with a single standard length guidewire. One radiopaque Platinum/lridium marker band is located within the balloon segment to aid in positioning the balloon in the stenosis, and are designed to provide an expandable segment of known diameter and length at a specific pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections and distal pressure measurements.
    Ask a Question

    Ask a specific question about this device

    K Number
    K211393
    Device Name
    Selethru(TM) NC PTCA Balloon Dilatation Catheter
    Date Cleared
    2021-07-02

    (58 days)

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

    Kossel Medtech (Suzhou) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Selethru™ NC PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
    Device Description
    The SelethruTM NC PTCA Balloon Dilatation Catheter is a rapid exchange (RX) PTCA Balloon Catheter used for the purpose of dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. And it is a sterile, single-use, intravascular medical device with a working length of 142cm. The non-compliant balloons are available in diameters 2.0 and 5.0mm and lengths from 6-30mm, and have a rated burst pressure of 22 atm for φ2.0 mm and 20 atm for φ5.0mm. The proximal shaft is PTFE coated stainless steel tube, which allows for exceptional push ability and a smooth transition to the distal shaft, which is composed of an outer tube, an inner tube, and a balloon. A hydrophilic coating is applied to the distal section. Moreover, the proximal shaft of the catheter has two marker sections of 5mm length that aid in gauging dilatation catheter position relative to the guiding catheter tip (marker located closest to the dilatation catheter adaptor is for femoral guiding catheters and the other marker is for brachial guiding catheters). The distal shaft of the catheter has an integrated shaft system. The shaft has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The other lumen, in the distal shaft, permits the use of a guide wire to facilitate advancement of the dilatation catheter to and through the stenosis to be dilated. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of the catheter with a single standard length guidewire Two radiopaque Platinum/Iridium marker bands are located within the balloon segment to aid in positioning the balloon in the stenosis, and are designed to provide an expandable segment of known diameter and length at a specific pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections and distal pressure measurements.
    Ask a Question

    Ask a specific question about this device

    K Number
    K182699
    Device Name
    Selethru PTCA Balloon Dilatation Catheter
    Date Cleared
    2018-11-26

    (60 days)

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

    Kossel Medtech (Suzhou) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Selethru PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
    Device Description
    The Selethru PTCA Balloon Dilatation Catheter is a rapid exchange (RX) PTCA Balloon Catheter used for the purpose of dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Selethru is a sterile, single-use, intravascular medical device with a working length of 142cm. The proximal shaft is PTFE coated stainless steel tube, which allows for exceptional pushability and a smooth transition to the distal shaft, which is composed of an outer tube, an inner tube, and a balloon. A hydrophilic coating is applied to the distal section. The semi-compliant balloons are available in diameters ranging from 1.5-4.0mm and lengths from 10-30mm, and have a rated burst pressure of 16 atm. The proximal shaft of the catheter has two marker sections of 5mm length that aid in gauging dilatation catheter position relative to the guiding catheter tip (marker located closest to the dilatation catheter adaptor is for femoral guiding catheters and the other marker is for brachial guiding catheters). The distal shaft of the catheter has an integrated shaft system. The shaft has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The other lumen, in the distal shaft, permits the use of a guide wire to facilitate advancement of the dilatation catheter to and through the stenosis to be dilated. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of the catheter with a single standard length guidewire. Two radiopaque Platinum/Iridium marker bands are located within the balloon segment to aid in positioning the balloon in the stenosis, and are designed to provide an expandable segment of known diameter and length at a specific pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections and distal pressure measurements.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1