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510(k) Data Aggregation

    K Number
    K220036
    Device Name
    Wellead Ureteral Catheter
    Manufacturer
    Well Lead Medical Co., Ltd.
    Date Cleared
    2022-12-16

    (345 days)

    Product Code
    KOD
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    KOD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ureteral Catheter is used for temporary urine drainage, delivery of irrigation fluids, injection of contrast agent to the urinary tract, navigation of a tortuous ureter, access, advancement or exchange of wire guides (open-ended catheters only).
    Device Description
    Ureteral Catheters are single-use and sterile devices, which consist of catheter, adapter and guide wire. Ureteral Catheters are available in a variety of French sizes and distal tip configurations. Ureteral Catheters have 5 different distal tip configurations, which are closed round tip, open tapered tip, open tip, open soft tip and open cone tip. The adapter and guide wire are optional and the choice of Ureteral Catheter, adapter and guide wire should be based on the physician's preference and clinical situation. The catheter tube is made of Polyvinylchloride (PVC). The catheter is uncoated. Recommend duration of use: less than 24 hours.
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    K Number
    K220730
    Device Name
    allFlex Ureteral Catheters, Krait Ureteral Catheters
    Manufacturer
    Allwin Medical Devices, Inc
    Date Cleared
    2022-10-13

    (213 days)

    Product Code
    KOD
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    KOD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Allwin Ureteral Catheters are used for drainage of urine from the ureter and they allow the delivery of contrast media.
    Device Description
    Not Found
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    K Number
    K211032
    Device Name
    Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
    Manufacturer
    UroGen Pharma Ltd
    Date Cleared
    2021-11-19

    (226 days)

    Product Code
    KOD, EZC, EZD
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    KOD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Urinary Catheter is indicated for use to facilitate access to the urinary tract through a retrograde route for the delivery of gels or fluids into the urinary tract.
    Device Description
    The Urinary Catheter is a single use 12 Fr or 16 Fr urethral catheter with a fixed female Luer lock hub. The catheter has a Coudé (Tiemann) tip, is 40 cm long. The catheter tube is made of Polyvinylchloride (PVC) and the Luer lock hub is made of Polycarbonate. The catheter is uncoated. The device is designed to assist in access to the urinary bladder using standard technique for drainage and delivery of gels or fluids. The catheter is indicated for use by healthcare professionals for facilitating access to the urinary tract through a retrograde route, for the delivery of gels or fluids into the urinary tract. The catheter is supplied sterile in a Tyvek pouch. The catheter is inserted into the body for a typical duration of less than 1 hour.
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    K Number
    K181979
    Device Name
    Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
    Manufacturer
    Teleflex Medical, Inc.
    Date Cleared
    2019-05-24

    (303 days)

    Product Code
    KOD, GBM
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    KOD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The subject device is a tubular device that is inserted through the urethra to pass urine from the bladder.
    Device Description
    The Teleflex Rusch®FloCath Quick™ 18 French (Fr.) Coudé Hydrophilic Intermittent Catheter is single use, disposable and sterile. The catheter is made of clear polyvinylchloride (PVC) with vertically cut and softly rounded, polished eyes and has a hydrophilic coating. It is composed of a shaft with a proximal funnel and a tip. The funnel is made of PVC. The shaft size is an 18 French gauge and is identified on the packaging. The funnel is color coded red to facilitate size identification. The catheter is 40 cm in overall length. The FloCath Quick is an integrated package that contains the FloCath catheter with a blue protective catheter sleeve and a packet of sterile 0.9% saline. Before opening, the sterile saline pouch is broken to hydrate the catheter. The protective catheter sleeve allows for touchless insertion. The sleeve can also be pushed back and used as an extension to the catheter. The FloCath Quick packaging has a packaging hole to facilitate opening the catheter. Either the packaging hole or the adhesive patch on the catheter pack can be used to hang up the catheter in an appropriate, convenient location while the catheter is hydrated.
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    K Number
    K180354
    Device Name
    UroGen Ureteral Catheter
    Manufacturer
    UroGen Pharma Ltd.
    Date Cleared
    2018-10-30

    (264 days)

    Product Code
    KOD, GBM
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    KOD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UroGen Ureteral Catheter is indicated for use by physicians for facilitating access to the urinary tract through a retrograde route and may be used in conjunction with a guidewire or for the injection of gels or fluids into the urinary tract.
    Device Description
    The device is a single use ureteral catheter, designed to assist in access to the upper urinary tract using standard endoscopic technique for drainage and delivery of gels or fluids. The catheter is indicated for use by physicians for facilitating access to the urinary tract through a retrograde route and may be used in conjunction with a guidewire or for the injection of gels or fluids into the urinary tract. The catheter is supplied sterile in a Tyvek pouch with a sterilization indicator. The catheter is inserted into the body for a typical duration of less than 1 hour. The catheter is placed over a guidewire of up to 0.038 inches in diameter that is prepositioned through the urological tract.
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    K Number
    K181144
    Device Name
    Angled Tip Ureteral Catheter
    Manufacturer
    Cook Incorporated
    Date Cleared
    2018-06-28

    (58 days)

    Product Code
    KOD
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    KOD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These devices are intended for access and catheterization of the urinary tract, including the following applications: - Delivery of contrast media - Navigation of a tortuous ureter - Access, advancement, or exchange of wire guides
    Device Description
    The Angled Tip Ureteral Catheter is constructed from polyurethane tubing and is designed with a female Luer lock adapter. The catheter is available in 5 and 6 French diameters and a length of 70 centimeters. The distal tip of the catheter has an angle of 20°, sideports, and a taper. The female Luer lock adapter is constructed from polyamide. The subject device also includes a stainless steel wire guide coated with PTFE. The wire guide diameter is 0.035 inches and the length is 145 centimeters
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    K Number
    K180530
    Device Name
    Imager II Urology Torque Catheter
    Manufacturer
    Boston Scientific Corporation
    Date Cleared
    2018-04-10

    (41 days)

    Product Code
    KOD
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    KOD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Imager II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the infusion of radiopaque contrast material. The Imager II Urology Torque Catheter is also indicated for the infusion of gels, such as BackStop™, intended for use in the urinary tract.
    Device Description
    The Imager II Urology Torque Catheter is single lumen, torqueable catheter that is offered with one of a variety of tip configurations, each uniquely designed to facilitate access to the urinary tract. This device is made of a bio-compatible polymer reinforced with a stainless steel braided wire with one hole at the distal tip and a luer lock hub is attached to the proximal end. The catheter may be used with a guidewire up to .038 in. diameter.
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    K Number
    K171810
    Device Name
    Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter
    Manufacturer
    Cook Incorporated
    Date Cleared
    2018-03-07

    (261 days)

    Product Code
    KOD
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    KOD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cone Tip Ureteral Catheter is intended for retrograde pyelogram. The Rutner Universal Wedge Catheter is intended for retrograde pyelogram. The 4.0 Fr Rutner Universal Wedge Catheter is indicated for pediatric population 2 years and older.
    Device Description
    **Cone Tip Ureteral Catheter:** The product consists of a straight, tipped catheter. The distal tip is in a cone formation and intended to temporarily occlude the ureteral orifice. The catheter tip and tubing shaft are made of radiopaque polyvinyl chloride material. The catheter is available in outer diameters of 4.8 and 6.0 French with corresponding tip diameters of 8.0 and 10.0 French respectively. The total working length of the device measures 70 centimeters. All French sizes are available with a closed distal end, except the 4.8 French catheters which are also available with an open end. Catheters with closed distal ends include one side port near the tip, whereas catheters with open distal ends do not include a side port. The radiopaque vinyl tubing shaft has an adapter on the proximal end and incremental graduation marks placed along the distal 50 centimeters of the catheter surface. **Rutner Universal Wedge Catheter:** The distal tip is made of polyvinyl chloride radiopaque material and its configuration is designed to occlude the ureteral orifice and stabilize the catheter by temporarily wedging the orifice. The catheter tubing shaft is manufactured from non-radiopaque nylon with an adapter located at the proximal end. The catheter is available in outer diameters of 4.0 or 5.0 French and a total device length of 70 centimeters. The outer diameter of the tip is available in 8.0 and 14.0 French. Based upon the device size, the distal tip may occlude an opening of 3.0 to 8.0 French or 4.0 to 14.0 French, respectively. A single sideport is located in the distal end of the catheter.
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    K Number
    K171600
    Device Name
    Renal Access Cobra Catheter, Kumpe Access Catheter
    Manufacturer
    Cook Incorporated
    Date Cleared
    2018-02-16

    (260 days)

    Product Code
    KOD
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    KOD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Renal Access Cobra Catheter: This device is intended for delivery of contrast media as well as access, advancement, or exchange of wire guides in the renal area. Kumpe Access Catheter: These devices are intended for access and catheterization of the urinary tract, including the following applications: Delivery of contrast media, Navigation of a tortuous ureter, Access, advancement, or exchange of wire guides
    Device Description
    The Renal Access Cobra Catheter consists of tubing with a proximal connector cap and a winged female Luer lock adapter. The catheter has a total length of 65 cm and an outer diameter of 6.0 French. The catheter tubing is composed of a polymer reinforced with braided wire. The distal end of the catheter has a hook shaped curve. The tubing French size and compatible wire guide size are printed on one side of the winged female Luer lock adapter; on the other side is the name of the manufacturer. The Kumpe Access Catheter consists of tubing with a proximal cap and female Luer lock adapter. The catheter has a total length of 65 cm and an outer diameter of 5.0 French. The catheter tubing is composed of a polymer reinforced with braided wire. The distal tubing configuration is angled at approximately 45 degrees. The tubing French size, compatible wire guide size, and manufacturer are printed on the cap.
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    K Number
    K171662
    Device Name
    Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter
    Manufacturer
    Cook Incorporated
    Date Cleared
    2018-02-01

    (241 days)

    Product Code
    KOD
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    KOD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ureteral catheters are indicated for access and catheterization of the urinary tract, including applications: - Delivery of contrast media - Drainage of fluids from the urinary tract - Delivery of irrigation fluids to the urinary tract - Navigation of a tortuous ureter - Access, advancement, or exchange of wire guides (open-ended catheters only) The Pediatric Ureteral Catheter is indicated for access and catheterization of the urinary tract in pediatric patients, including the following applications: - Delivery of contrast media - Drainage of fluids from the urinary tract - Delivery of irrigation fluids to the urinary tract - Navigation of a tortuous ureter
    Device Description
    The Ureteral Catheter family is comprised of nine different types of Ureteral Catheters. The types of catheters include: Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, and Pediatric Ureteral Catheter. The Ureteral Catheters range in length from 10 to 125 cm. The catheters may be closed or open-ended. The Ureteral Catheters are sterile, single-use devices.
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