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510(k) Data Aggregation

    K Number
    K151084
    Device Name
    Well Lead Ureteral Access Sheath
    Manufacturer
    WELL LEAD MEDICAL CO. LTD
    Date Cleared
    2016-01-07

    (260 days)

    Product Code
    FED
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    WELL LEAD MEDICAL CO. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Well Lead Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract.
    Device Description
    The Well Lead Ureteral Access Sheath is a single use sterile device, provides ureteral dilation and a continuous working channel for the introduction of endoscopes and instruments during ureteral access procedures. The Ureteral Access Sheath is comprised of three components: sheath, dilator and connector. The outer surface of the sheath has a hydrophilic coating. When activated, the hydrophilic feature allows for easier insertion and removal of the sheath. The sheath is offered in three French sizes: 10Fr, 12Fr and 14Fr, and range in length from 13cm (shortest) to 55cm (longest).
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    K Number
    K140667
    Device Name
    WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER
    Manufacturer
    WELL LEAD MEDICAL CO. LTD
    Date Cleared
    2014-12-15

    (272 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    WELL LEAD MEDICAL CO. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Well Lead Hydrophilic Silicone Foley Catheter is intended for use for bladder management including urine drainage, collection and measurement. The Catheter is passed through the urethra during urinary catheterization and into the bladder to drain urine. The Three-way Catheter provides a lumen that is used for bladder irrigation.
    Device Description
    The Well Lead Hydrophilic Silicone Foley Catheter is sterile, single patient use, urinary drainage catheter that is made from silicone and with a hydrophilic coating. The Catheter is available in two types, Two-way and Three-way Silicone Foley Catheter, it is supplied in French size ranging from 6 to 26 and balloon size 1.5cc to 30cc. The 6Fr, 8Fr and 10Fr catheters are for pediatric, and others are for adult.
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    K Number
    K133615
    Device Name
    WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER
    Manufacturer
    WELL LEAD MEDICAL CO. LTD
    Date Cleared
    2014-02-24

    (91 days)

    Product Code
    EZD
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    WELL LEAD MEDICAL CO. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Well Lead PVC Hydrophilic Urethral Catheter is launched for clean intermittent catheterization-CIC treatment and indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.
    Device Description
    The Well Lead PVC Hydrophilic Urethral Catheter is a flexible tubular single use urinary catheter that is inserted through the urethra to allow drainage of the bladder. The device consists of disposable polyvinyl chloride catheter (medical grade PVC) coated with hydrophilic polymer. When the catheter is immersed in water for 30 seconds it becomes slippery and ready to use. The catheters come in sizes from 12Fr-24Fr for Male, 12Fr-24Fr for Female and 6Fr-10Fr for Pediatric.
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    K Number
    K110269
    Device Name
    WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL
    Manufacturer
    WELL LEAD MEDICAL CO. LTD
    Date Cleared
    2011-08-26

    (211 days)

    Product Code
    BTR, BSY
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    WELL LEAD MEDICAL CO. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for Oral intubation and drainage of the subglottic space for airway management.
    Device Description
    Well Lead Endotracheal Tube with Evacuation Lumen-Oral (6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm) The Well Lead Endotracheal Tube with Evacuation Lumen is sterile; single-use devices supplied with a standard 15mm connector. It is made of Polyvinylchloride. In addition to the main lumen, the tube has a separate lumen which has a dorsal opening above the cuff. Access to the lumen is accomplished via a clear connecting tube with a capped Luer connector. The tube incorporates a Magill curve, a tip with Murphy Eye and a radiopaque line to assist in radiographic visualization.
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    K Number
    K091516
    Device Name
    WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR
    Manufacturer
    WELL LEAD MEDICAL CO. LTD
    Date Cleared
    2009-10-16

    (147 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    WELL LEAD MEDICAL CO. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Well Lead All Silicone Foley Catheters With Temperature Sensor are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals.
    Device Description
    The Well Lead all Silicone Foley Catheters with Temperature are two-way Foley Catheters which are used in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals.
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