Search Filters

Search Results

Found 5 results

510(k) Data Aggregation

    K Number
    K200317
    Device Name
    Support Catheter
    Manufacturer
    QXMedical, LLC
    Date Cleared
    2020-05-14

    (97 days)

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

    QXMedical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The support catheter is intended for use during coronary and peripheral interventional procedures to guide and support guidewires, traverse discrete portions of the vasculature, allow for guidewire exchanges and provide a conduit for infusion of saline solution, diagnostic contrast agents and therapeutic agents.
    Device Description
    The subject Support Catheter is an over-the-wire (OTW) single-lumen catheter with a tapered atraumatic tip. The catheter is available in fifteen (15) size models compatible with standard 0.014", 0.018" and 0.035" diameter guidewires and with effective lengths of 65 cm, 90 cm, 135 cm, 150 cm and 180 cm. The distal end of the catheter incorporates three (3) distal radiopaque markers to assist with fluoroscopic guidance and estimating distances. A hydrophilic coating on the distal end assists with catheter advancement. The proximal end of the catheter has a molded manifold with a female luer connection in fluid communication with the catheter lumen. The catheter lumen is used for guidewire passage and exchanges as well as fluid infusion. The catheter guidewire size and length are printed on the strain relief. The device is supplied sterile and intended for single use only.
    Ask a Question
    K Number
    K183679
    Device Name
    Occlusion Balloon Catheter
    Manufacturer
    QXMedical, LLC
    Date Cleared
    2019-04-24

    (117 days)

    Product Code
    MJN
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    QXMedical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Occlusion Balloon Catheter is indicated for temporary occlusion of large vessels, including the superior vena cava, in applications including perioperative occlusion and emergency control of hemorrhage.
    Device Description
    The Occlusion Balloon Catheter is a multi-lumen catheter which has a compliant polyurethane balloon with a maximum diameter of 32mm at 60cc inflation volume. The balloon has a nominal length of 80mm. The device is constructed with a blended PEBA shaft and is available in two models; one model is compatible with 8Fr (or larger) introducer sheaths and one model is compatible with 10Fr (or larger) introducer sheaths. Both models provide the same balloon performance with respect to sizing and occlusion. The two models are intended for individual physician preference for patient-specific sheath selection. The device has an effective length of 90cm and is compatible with 0.035" diameter guidewires. Three (3) platinum-iridium radiopaque marker bands are placed on the shaft to facilitate balloon placement in the anatomy prior to inflation. The proximal end of the catheter has an integral PEBA bifurcation manifold with female luer ports to allow communication with the balloon inflation lumen and guidewire lumen. A PVC extension tube (with stopcock) is connected to the balloon inflation port to facilitate handling. The device is a single use, sterile device.
    Ask a Question
    K Number
    K160561
    Device Name
    Boosting Catheter
    Manufacturer
    QXMEDICAL, LLC
    Date Cleared
    2016-11-02

    (247 days)

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

    QXMEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Boosting Catheter is intended for use in conjunction with guiding catheters or sheaths during coronary and peripheral interventional procedures to guide and support interventional devices, including guidewires, traverse discrete portions of the vasculature, allow for interventional device exchanges and provide a conduit for infusion of saline solution, diagnostic contrast agents and therapeutic agents.
    Device Description
    The Boosting Catheter is an over-the-wire percutaneous catheter with an atraumatic tip. The catheter has an effective length of 150cm and available in four (4) diameter models; each compatible with various guiding catheters or sheaths as shown in the following table: | Catalog<br>Number | Model<br>Number | Catheter<br>I.D. | Catheter<br>O.D. | Compatible<br>Guiding Catheter | Compatible<br>Sheath | |-------------------|-----------------|------------------|------------------|--------------------------------|------------------------| | BC52-150 | 9005-001 | 0.052" | 0.064" | 6 Fr (0.066" MIN ID) | 5 Fr (0.066" MIN ID) | | BC57-150 | 9005-002 | 0.057" | 0.068" | 6 Fr (0.070" MIN ID) | 5.5 Fr (0.072" MIN ID) | | BC63-150 | 9005-003 | 0.063" | 0.076" | 7 Fr (0.078" MIN ID) | 6 Fr (0.079" MIN ID) | | BC72-150 | 9005-004 | 0.072" | 0.086" | 8 Fr (0.088" MIN ID) | 7 Fr (0.092" MIN ID) | The Boosting Catheter is constructed with a proximal manipulation shaft connected to a distal tube or guiding catheter segment. The manipulation shaft is used to advance the distal tube segment over a guidewire and through a guiding catheter (or sheath) to a desired location in the coronary or peripheral vasculature. Once positioned, diagnostic or interventional devices (including guidewires) may be delivered or exchanged though the guiding catheter and the Boosting Catheter distal tube segment. Further, procedural fluids (such as saline, contrast agents or therapeutic agents) can be delivered through the guiding catheter and the distal tube segment to a desired location in the coronary or peripheral vasculature. The distal tube segment has two (2) radiopaque markers to facilitate fluoroscopic guidance and a lubricious outer coating to assist with catheter advancement. The manipulation shaft has a molded handle and strain relief to assist with handling. The strain relief is printed with the catheter dimensional information. The device is supplied sterile and intended for single use only.
    Ask a Question
    K Number
    K123311
    Device Name
    QXMEDICAL ACCESS & SUPPORT CATHETER
    Manufacturer
    QXMEDICAL, LLC
    Date Cleared
    2013-01-14

    (81 days)

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

    QXMEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Access & Support Catheter is intended for use during coronary and peripheral interventional procedures to guide and support guidewires, traverse discrete portions of the vasculature, allow for guidewire exchanges and provide a conduit for infusion of saline solution, diagnostic contrast agents and therapeutic agents.
    Device Description
    The Access & Support Catheter is an over-the-wire (OTW) single-lumen catheter with an atraumatic tapered tip. The catheter is offered in twelve (12) size models as outlined in the following table. The catheter shaft consists of high density polyethylene (HDPE) with distal platinum/iridium markerbands. The distal 40 cm outer portion of all catheters have a hydrophilic coating. The proximal portion includes a PEBA strain relief with a HDPE manifold which incorporates a female luer connection which communicates with the catheter lumen. The catheter through lumen is used to pass the catheter over the appropriate guidewire or for infusion. When used for infusion, the maximum infusion pressure should not exceed 300 psi. The catheter guidewire compatibility size and length are printed on the strain relief. All models are compatible with 5 Fr introducer sheaths and 6 Fr guiding catheters. All devices are provided sterile and intended for single use only.
    Ask a Question
    K Number
    K120381
    Device Name
    Q50 PLUS STENT GRAFT BALLOON CATHETER
    Manufacturer
    QXMEDICAL, LLC
    Date Cleared
    2012-02-24

    (17 days)

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

    QXMEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.
    Device Description
    The OXMédical Stent Graft Balloon Catheter is a multi-lumen catheter which has a compliant polyurethane balloon with a maximum diameter of 50mm at 60cc inflation volume. The device is constructed with an 8Fr diameter blended PEBA shaft and is available in two usable lengths, 65 cm and 100 cm. The device is compatible with 12Fr (or larger) introducer sheaths and 0.038" diameter (or smaller) guidewires. Two platinum-iridium radiopaque marker bands are placed within the balloon to facilitate balloon placement prior to inflation. The proximal end of the catheter has an integral PEBA bifurcation manifold with female luer ports to allow communication with the balloon inflation lumen and guidewire lumen. A PVC extension tube (with stopcock) is connected to the balloon inflation port to facilitate handling. The device is a single use, sterile device.
    Ask a Question

    Page 1 of 1