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510(k) Data Aggregation

    K Number
    K250910
    Device Name
    Optilume® High Pressure Urological Balloon Dilation Catheter
    Manufacturer
    Urotronic, Inc.
    Date Cleared
    2025-05-22

    (57 days)

    Product Code
    EZN, KOE
    Regulation Number
    876.5470
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Optilume® High Pressure Urological Balloon Dilation Catheter is indicated for dilation of the urinary tract.
    Device Description
    The Optilume® High Pressure Urological Balloon Dilation Catheter is an 0.038" (0.97mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume® High Pressure Urological Balloon Dilation Catheter is used to exert radial force to dilate narrow urinary tract segments (strictures). The distal end of the catheter is a non-compliant inflatable balloon. The 75 cm long Optilume® High Pressure Urological Balloon Dilation Catheter is supplied in five balloon diameters ranging from 4-10mm and balloon lengths ranging from 20-80mm. The balloon catheter is supplied sterile for single use.
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    K Number
    K220781
    Device Name
    ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
    Manufacturer
    Allwin Medical Devices, Inc
    Date Cleared
    2023-05-05

    (414 days)

    Product Code
    EZN, LJE
    Regulation Number
    876.5470
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ARMADA Ureteral Dilator Set: Used for step by step dilatation of the intramural and ureter and / or for stone manipulation. ARMADA Nottingham One Step Dilator: Used for one step dilatation of the intramural portion and ureter. ARMADA Amplatz Renal Dilator Set: Used for progressive dilatation for tract prior to percutaneous kidney stone removal. ARMADA Renal Dilator: Used for dilatation of Renal Tract. Glider Amplatz Sheath: Used to maintain previously established nephrostomy tract. Fascial Dilator: Fascial Dilators are used for dilatation of percutaneous track over the guidewire. Introducer Sheath: Used for introducing safety wire during nephrostomy. Introducer Catheter: Used for guiding renal dilators for establishing nephrostomy tract.
    Device Description
    Not Found
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    K Number
    K201007
    Device Name
    In-Ka Ureteral Balloon Dilatation Catheter
    Manufacturer
    Coloplast Corp
    Date Cleared
    2020-06-11

    (55 days)

    Product Code
    EZN
    Regulation Number
    876.5470
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In-Ka® ureteral balloon dilatation catheters are intended for: - . Dilation of ureteral meatus and/or ureteral canal during endoscopic procedures - . Treatment of ureteral stenosis
    Device Description
    The In-Ka Ureteral Balloon Dilatation Catheter is a urinary balloon catheter intended for dilation of the ureteral meatus or the ureteral canal or for treatment of ureteral stenosis. The catheter is a double lumen catheter with a balloon at the distal end and supplied in three balloon diameters ranging from 4 - 6 mm. Each 75 cm long In-Ka catheter is supplied sterile for a single use. Either a manometer or a 10cc syringe is included for balloon inflation.
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    K Number
    K190612
    Device Name
    EQUINOX Balloon Dilatation Catheter
    Manufacturer
    Dornier MedTech America Inc
    Date Cleared
    2019-12-06

    (270 days)

    Product Code
    EZN, KOE
    Regulation Number
    876.5470
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dornier EQUINOX Balloon Dilatation Catheter is indicated for dilation of the urinary tract.
    Device Description
    The Dornier EQUINOX Balloon Dilatation Catheter is a multiple lumen catheter with a dilatation balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow ureteral segments. The Dornier EQUINOX Balloon Dilatation Catheters are sterile, single-use devices. The EQUINOX Balloon Dilatation Catheters are available in 5.8 French (Fr) diameter, with a catheter length of 80 centimeters (cm). There will be three (3) balloon diameters, (4mm, 5mm and 6mm) and two (2) balloon lengths (4cm and 10cm) The Dornier EQUINOX Balloon Dilatation Catheters are constructed of a medical grade nylon material. This material has been USP Class VI tested. The base material is compounded with BaSO4 to render the Dornier EQUINOX Balloon Dilatation Catheter radiopaque under x-ray fluoroscopy. The catheter also has radio-opaque marker bands on the proximal and distal ends of the balloon for visualization during use. All colorants used are compliant with FDA standards.
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    K Number
    K173654
    Device Name
    Ureteral Dilator Sets, Ureteral Dilators
    Manufacturer
    Cook Incorporated
    Date Cleared
    2018-07-17

    (231 days)

    Product Code
    EZN
    Regulation Number
    876.5470
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ureteral Dilator Sets are intended for the dilation of the ureter prior to ureteroscopy or stone manipulation. The Ureteral Dilators are intended for the dilation of the ureteroscopy or stone manipulation.
    Device Description
    The Ureteral Dilator Sets, and each individual Ureteral Dilator, are used for dilation of the ureter prior to ureteroscopy and/or stone manipulation. The Ureteral Dilator Sets are available in one of three sets: a set of 6 dilators, a set of 7 dilators and a wire guide, or a set of 9 dilators and a wire guide. The dilators are manufactured from either radiopaque ethylene vinyl acetate (EVA) or fluorinated ethylene propylene (FEP). Dilators manufactured with EVA are also available with hydrophilic coating. Dilators are also available individually. The wire guide is a stainless steel fixed core wire guide. The Ureteral Dilators and the Ureteral Dilator Sets are sterilized by ethylene oxide and intended for one-time use. All Ureteral Dilators are manufactured with a length of 60 centimeters and range from 6.0 French to 18.0 French in diameter. The distal end of the dilators is tapered to a 0.040inch diameter endhole with the taper measuring 0.8-2.5 centimeters from the distal end, depending on the device French size. Additionally, the French size of each dilator is stamped at the proximal end. The stainless steel fixed cored wire guide is manufactured with a diameter of 0.038 inches (0.97 millimeters) and a length of 145 centimeters.
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    K Number
    K180756
    Device Name
    Safety Wire Guide Introducer
    Manufacturer
    COOK Incorporated
    Date Cleared
    2018-05-24

    (63 days)

    Product Code
    EZN
    Regulation Number
    876.5470
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Safety Wire Guide Introducer is used for antegrade placement of a safety wire guide prior to endourological procedures.
    Device Description
    The Safety Wire Guide Introducer is used for antegrade placement of a safety wire guide prior to endourological procedures. The Safety Wire Guide Introducer includes an obturator and sheath. The radiopaque polyethylene obturator is 7.0 French, 25.7 cm in length, and has a 1 cm taper along the distal tip of the device. It can be inserted through the radiopaque polyethylene introducer sheath that is 12.0 French, 22.2 cm in length, and tapers 6 mm from the distal end of the device.
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    K Number
    K180028
    Device Name
    Cook 810 Set, Desilets-Hoffman Introducer Set
    Manufacturer
    Cook Incorporated
    Date Cleared
    2018-05-02

    (119 days)

    Product Code
    EZN
    Regulation Number
    876.5470
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cook 810 Set is used for retrograde or antegrade ureteral access and to facilitate wire guide exchange. The Desilets-Hoffman Introducer Set is used for retrograde or antegrade ureteral access and to facilitate wire guide exchange.
    Device Description
    The Ureteral Introducer Sets is a bundle of two Ureteral Introducer Sets, composed of the Cook® 810 Set and Desilets-Hoffman Introducer Set. The Cook 810 Set is composed of a dilator and a delivery sheath, which is used for retrograde or antegrade ureteral access and to facilitate wire guide exchange. To use this device, antegrade (i.e., through a percutaneous tract) or retrograde (i.e., transurethral) access is achieved using a wire guide up to 0.038 inches in outer diameter, using standard access techniques. Next, the dilator is inserted over the wire guide and used to dilate the ureter/ureteral orifice. The physician would then place the delivery sheath over the dilator to dilate the anatomy to 10 French before placing the tip of the sheath into the desired anatomical location. The dilator is withdrawn while maintaining the position of the introducer sheath. Wires may then be placed/exchanged through the sheath, and the delivery sheath is subsequently removed from the patient. The dilator is an outer diameter of 8 French and 88 centimeters (cm) in length. Both ends of the dilator have smooth round tips and both tips are tapered at 5 millimeters (mm) as well. The sheath is an outer diameter of 8.5 French and 30 or 50 cm in length, depending on the selected set. The Desilets-Hoffman Introducer Set is used for retrograde or antegrade ureteral access and to facilitate wire guide exchange. The Desilets-Hoffman Introducer Set includes a delivery sheath and dilator. The delivery sheath is 10 French and 30 cm in length. The dilator is 8 French and available in 70 or 88 cm in length. One of the sets ("RB" version) has a radiopaque band on the delivery sheath to aid in fluoroscopic visualization during placement.
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    K Number
    K172588
    Device Name
    Balloon Catheter and Balloon Ureteral Dilator Set
    Manufacturer
    Cook Incorporated
    Date Cleared
    2018-04-19

    (233 days)

    Product Code
    EZN
    Regulation Number
    876.5470
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Balloon Ureteral Dilator and Balloon Ureteral Dilator Set is intended for ureteral dilation prior to ureteral stone manipulation or ureteroscopy and dilation of the intramural ureter.
    Device Description
    The Balloon Ureteral Dilator Set includes the balloon ureteral dilator, a wire guide, a 10 mL syringe, an endoscopic cap and a pin-vise handle. Balloon ureteral dilators can be purchased separately. The balloon ureteral dilator is composed of a radiopaque dilator fitted with a polyethylene balloon. The balloon ureteral dilator is available in 5.0 or 7.0 French and is 65 centimeters in length. The balloon is located on the distal end of the dilator and has diameters of 5 or 6 millimeters with lengths of 4 or 10 centimeters when inflated. The balloon has a maximum inflation pressure of 40 or 60 psi, depending on the diameter and length of the balloon. Additionally, radiopaque marker bands are placed at the proximal and distal ends of the balloon to provide fluoroscopic visibility. Additional set components in the Balloon Ureteral Dilator Set include a straight safety wire guide, endoscopic cap, pin-vise handle, and syringe. The wire guide has a diameter of 0.028 or 0.038 inches and a length of 145 centimeters. The endoscopic cap and a pin-vise handle are provided to stabilize the wire guide during introduction. The syringe is a 10 mL luer-lock syringe provided for balloon inflation. The Balloon Ureteral Dilator and Balloon Ureteral Dilator Set is provided sterile for one-time use.
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    K Number
    K170531
    Device Name
    Ureteral Dilators and Percutaneous Nephrostomy Dilators
    Manufacturer
    Coloplast Corp
    Date Cleared
    2017-08-17

    (176 days)

    Product Code
    EZN
    Regulation Number
    876.5470
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ureteral Dilators: Intended to be used for dilatation of the ureter during ureteroscopic procedures. Percutaneous Nephrostomy Dilators: Dilator for tract preparation or splittable working sheath to protect the parenchyma.
    Device Description
    Ureteral dilators: The Ureteral Dilators are hollow rigid tubes made of Polyether Block Amide (PEBA) with tapered tips at the distal and proximal end. Total length is approximately 48 cm. The dilators are compatible with a 0.038 inch (0.97 mm) guidewire. Outer diameters are either: - CH FR 08 at one end and CH FR 10 at the other end - CH FR 12 at one end and CH FR 14 at the other end ● Percutaneous Nephrostomy (PCN) dilators: The simple dilators are hollow tubes made in Polyether Block Amide (PEBA), with a tapered distal tip and straight cut proximal end. Total length is approximately 21cm. The dilators are compatible with a 0.038 inch (0.97mm) guide-wire. The dilator with splittable sheath consists of a high-density polyethylene (HDPE) dilator fitted with a Polytetrafluoroethylene (PTFE) sheath.
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    K Number
    K132181
    Device Name
    GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER
    Manufacturer
    OLYMPUS SURGICAL TECHNOLOGIES AMERICA
    Date Cleared
    2013-10-21

    (98 days)

    Product Code
    EZN, KOE
    Regulation Number
    876.5470
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter is recommended for dilation of the urinary tract.
    Device Description
    The Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter is a reinforced catheter attached to a distal dilatation balloon. It has a radiopaque tip and two radiopaque markers positioned inside the balloon that define the working length. The balloon catheter can be used to dilate strictures of the urinary tract.
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