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510(k) Data Aggregation

    K Number
    K192183
    Device Name
    RocaTub Ureteral Catheter
    Manufacturer
    Promepal Sam
    Date Cleared
    2020-04-23

    (255 days)

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

    EYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RocaTub ureteral catheter is intended for use during ureteral catheterization for drainage, opacification of the upper urinary tract (retrograde ureteropyelography) and flushing procedures for diagnostics or interventional endourology procedures (stone management, stricture management) on adults.
    Device Description
    The Rocamed RocaTub Catheters consist of a flexible tube, tapered, perforated and with position marks. It is radio-opaque and hydrophilic coated. The device includes a stylet for easing insertion into the patient if needed and a connector for syringe for flushing procedures. The device is offered in various sizes, from 4 to 7 Fr in 80cm length, and with various tip shapes.
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    K Number
    K191187
    Device Name
    Dornier MINNOW Ureteral Catheter
    Manufacturer
    Dornier MedTech America Inc
    Date Cleared
    2019-09-18

    (138 days)

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

    EYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dornier MINNOW Ureteral catheter is indicated for access and catheterization of the urinary tract, 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 Access, advancement, or exchange of wire quides The target population is for adults only (at least 22 years old).
    Device Description
    The MINNOW Ureteral Catheter is a sterile single lumen medical grade thermoplastic elastomer (Pebax®) catheter. It is designed to assist in access to the upper urinary tract using standard endoscopic technique for drainage and delivery of gels or fluids. The device is offered without side holes and is available in 5 and 6 Fr. Sizes, which are common to the industry. 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 quidewire or for the injection of gels or fluids into the urinary tract. The catheter tip is radiused and has a .041" ID that allows for a smooth transition and passage when placed over a guidewire of up to 0.038" inches in diameter that is pre-positioned through the urological tract. The MINNOW Ureteral Catheters are packaged with a standard Touhy-Borst adapter that allows for injection or aspiration of fluids, but removable to allow for scope exchange without having to remove the catheter. The MINNOW Ureteral Catheters are available in 5 and 6 French (Fr) diameter, with a catheter length of 70 centimeters (cm).
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    K Number
    K183323
    Device Name
    UPJ Occlusion Balloon Catheter
    Manufacturer
    COOK Incorporated
    Date Cleared
    2019-08-05

    (248 days)

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

    EYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used to temporarily occlude the ureteropelvic junction to prevents from entering the ureter during percutaneous lithotripsy, and for injection of contrast medium.
    Device Description
    The UPJ Occlusion Balloon Catheter is composed of a balloon catheter, a removable inflation/injection adapter, a 1 mL syringe, and a wire guide assembly. The UPJ Occlusion Balloon Catheter is manufactured from a double lumen polyurethane radiopaque tubing with a working length of 75 centimeters. The smaller lumen is designed for balloon inflation, while the larger lumen fits over the wire guide assembly. The distal balloon is manufactured from silicone and has an approximate inflation volume of 4 mL. The inflation/injector adapter is removable, allowing for a cystoscope to be removed after the catheter is in place. The wire guide assembly is manufactured in 0.028- or 0.038-inch diameter stainless steel coils. The stainless-steel coils are coated with polytetrafluoroethylene and measure 80 centimeters. The wire guide assembly is designed to be placed through the small lumen of the balloon catheter. The UPJ Occlusion Balloon Catheter is supplied sterile, intended for one-time use only, and packaged in a peel-open pouch with a shelf-life of 3 years.
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    K Number
    K182695
    Device Name
    Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
    Manufacturer
    Cook Incorporated
    Date Cleared
    2019-06-17

    (263 days)

    Product Code
    EYB, DEV
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    EYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for drainage or irrigation in the urinary tract as well as access, advancement, or exchange of wire guides.
    Device Description
    The Pigtail Ureteral Catheter Sets consist of a catheter and wire guide. The catheters are constructed from polyurethane tubing and have a proximal female Luer lock adapter constructed from polyamide. The catheters are available in 5, 6, and 7 French (Fr) and a length of 70 centimeters (cm). The distal end of the catheter has a single pigtail loop with six sideports. The catheter has ink marks denoting depth and body orientation. The stainless steel wire guides are coated with polytetrafluoroethylene (PTFE) and available in diameters of 0.038 and 0.045 inches (in) with a length of 145 cm. The Pigtail Ureteral Catheter Sof-Flex® AO® is a catheter with a hydrophilic coating. The catheters are constructed from polyurethane tubing and have a female Luer lock adapter constructed from polyamide. The catheters are available in 8.2 and 10 Fr and have a length of 56 cm. The distal end of the catheter has a single pigtail loop with 5 evenly spaced sideports around the pigtail loop. There are also 6 sideports spaced at 1 cm intervals just proximal to the pigtail loop on the same side of the catheter. For the next 10 cm after the sideports, on the straight portion of the catheter, there are no sideports. After which, there are 9 sideports placed at 1 cm intervals spiraled around the catheter across 8 cm. The subject devices are provided sterile and are intended for one time use.
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    K Number
    K182122
    Device Name
    Ureteric Catheters
    Manufacturer
    Coloplast Corp
    Date Cleared
    2018-10-04

    (59 days)

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

    EYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ureteric catheters for retrograde ureteropyelography are intended for injection of contrast medium or saline during endourological procedures.
    Device Description
    The Ureteric Catheters for retrograde ureteropyelography are flexible tubular devices designed with open proximal and distal ends. The bulb shaped distal end permits the catheter to enter the lowest part of the ureter maintaining water tightness when injecting contrast or saline. The Ureteric Catheters are made from a polyvinyl chloride (PVC) material and have soft bulbous tip to help position the device in the ureter meatus. The devices are provided sterile and are intended for single use. The Ureteric Catheters have a Chevassu open tip, do not have side eyes, and range in diameter from 3 Fr to 7 Fr for the catheter body and 4 Fr to 10 FR for the Chevassu bulb. They are supplied with a metal stylet to facilitate insertion and a Luer-lock syringe connector. They are provided in two lengths, 69.5 and 73 cm. The longer version is intended to be compatible with a 0.035" guidewire. The shaft is marked at one centimeter increments along the length to aid in advancement and is radiopaque for fluoroscopic visualization.
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    K Number
    K180182
    Device Name
    Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter
    Manufacturer
    Cook Incorporated
    Date Cleared
    2018-09-14

    (234 days)

    Product Code
    EYB, DEV
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    EYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for injection of contrast medium and/or safety wire guide placement during percutaneous and transurethral access. The catheters that are 24 cm and 40 cm in length can be used in pediatric patients 12 years and over.
    Device Description
    The Dual Lumen Ureteral Access Catheter is constructed from a dual-lumen, polyurethane tubing with ink marks and a tubing manifold with extension tubes. The catheter has a working length of 50 cm. The outer diameter of the catheter is 10.0 Fr and both lumens' inner diameter is 0.050 inches. The distal tip is notched to expose one lumen and create a 5.0 Fr tip with the other lumen. This device is manufactured both with and without a hydrophilic coating. The Flexi-Tip® Dual Lumen Ureteral Access Catheter is constructed from a dual-lumen, polyurethane tubing with ink marks and a tubing manifold with extension tubes. The catheter is available in lengths of 24, 40, and 50 cm. The outer diameter of the catheter is 10.0 Fr and both lumens' inner diameter is 0.050 inches. The distal tip is notched to expose one lumen and a flexible polyurethane tip is bonded to the tip of the other lumen. The Flexi-Tip® Dual Lumen Ureteral Access Catheter is available with hydrophilic coating and a radiopaque urethane tungsten marker. The Dual Lumen Ureteral Access Catheter and the Flex-Tip® Dual Lumen Ureteral Access catheters are sterilized by ethylene oxide and are packaged in peel-open pouches for single use.
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    K Number
    K171043
    Device Name
    Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters
    Manufacturer
    Coloplast Corp
    Date Cleared
    2017-12-21

    (258 days)

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

    EYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ureteric catheters are intended for endourological procedures, to restore or maintain drainage of the upper urinary tract and to inject contrast medium or saline. Duration of use: Ureteric catheters are intended for temporary use during surgical procedure.
    Device Description
    Ureteric catheters are ethylene oxide sterilized, single use devices intended to restore or maintain drainage of the upper urinary tract and to flush or inject contrast medium or saline during an endoscopic procedure. All ureteric catheters include a connector nut with a Luer fitting. The connector nut is inserted into the proximal end of the catheter allowing the Luer fitting to connect to collecting or injection devices. Ureteric catheters are open at the distal end (farthest away from the surgeon) to allow use over a guidewire. Flush Ureteric Catheters and Ureteric Catheters come in three different tip configurations (straight, open coudé with side eyes, open coudé without side eyes). A stylet in included with the catheters to aid during the catheter insertion. The Flush Ureteric Catheters and Ureteric Catheters are supplied in a 74 cm length and diameters range from 3 Fr. to 8 Fr. The Floppy Tip Hydro-coated Ureteric catheters are 70 cm long and have 5,6, and 7 Fr. diameters. The Flush Ureteric Catheters and Ureteric Catheters are made from polyether block amide materials. The Floppy Tip Hydro-coated Ureteric catheters are made from polyvinyl chloride (PVC), have a hydrophilic coating over the distal tip (farthest away from the surgeon), and a soft tip which allows for easier insertion and advancement of the catheter. The materials have a radiopaque filler to allow for fluoroscopic visibility.
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    K Number
    K133750
    Device Name
    OCCLUDER OCCLUSION BALLOON CATHETER
    Manufacturer
    Boston Scientific Corporation
    Date Cleared
    2014-01-08

    (30 days)

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

    EYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Occluder™ Occlusion Balloon Catheters are indicated for use for temporary Ureteral occlusion and applications including, renal opacification, dislodgment of calculi and preventative calculi migration.
    Device Description
    Occluder Occlusion Balloon Catheters are designed for use for temporary occlusion of the ureter and applications including renal opacification, dislodgement of calculi and preventative calculi migration. The devices are provided sterile and are intended for single use. The Occluder Occlusion Balloon Catheters are constructed of a soft compliant latex balloon mounted on the tip of a catheter shaft. Catheter shafts are radiopaque, maximizing fluoroscopic visibility. The Occluder Occlusion Balloon Catheters have two lumens that are marked and color-coded. The balloon tubing, marked BALLOON is a balloon inflation lumen. The tubing marked DISTAL, is the essential lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. This lumen can also be used for infusion of contrast medium.
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    K Number
    K092250
    Device Name
    MEDLINE RED RUBBER URETHRAL CATHETER
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2010-01-21

    (177 days)

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

    EYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medline's urethral catheter is a flexible tubular device that is intended for use in the drainage of fluid from the urinary tract.
    Device Description
    flexible tubular device
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    K Number
    K083788
    Device Name
    ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR
    Manufacturer
    ENDO OPTIKS, INC.
    Date Cleared
    2009-03-03

    (74 days)

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

    EYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stonebuster Endoscopic System for Stone Removal (SESSR) Catheter for Endoscopy is intended to provide access to the ureteral canal and to be used to guide the currently available visualization devices and accessory devices such as bionsy forceps, cytology brushes, stone retrieval baskets, etc. during endoscopic procedures. The indications for use of the catheter are in urological applications.
    Device Description
    The Stonebuster Endoscopic System for Stone Removal (SESSR) Delivery Catheter is a sterile, single-use device comprised of one main component: a flexible triple lumen delivery catheter with three Luer-Lock delivery ports. This device is intended to provide access to the ureteral canal and to be used to guide the currently available visualization devices and accessory devices such as biopsy forceps, cytology brushes, stone retrieval baskets, etc. during endossopic procedures. The SESSR Delivery Catheter is introduced into the desired anatomical location through the SESS sheath with a minimum working channel diameter of 4.3mm. The distal tip of the SESSR is straight or benefit at minimum of 6.5 mm from the distal tip of 10 degrees providing the physician with (when using visualization devices) a wider field of view.
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