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510(k) Data Aggregation

    K Number
    K191061
    Device Name
    Optilume Basic Urological Balloon Dilation Catheter
    Manufacturer
    Urotronic Inc
    Date Cleared
    2020-01-02

    (255 days)

    Product Code
    KOE
    Regulation Number
    876.5520
    Why did this record match?
    Product Code :

    KOE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Optilume Basic Urological Balloon Dilation Catheter is indicated for the dilation of urethral strictures.
    Device Description
    The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038" (0.97 mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume Basic is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter is a semi-compliant inflatable balloon. The usable length is 75 cm and allows the device to be compatible with the working channel of a standard flexible cystoscope. The device has two radiopaque marker bands that indicate the working length of the balloon. The device is sterilized using ethylene oxide in a Tyvek pouch. Post sterilization the pouched catheter is sealed in a foil pouch with desiccant and contained within a single unit carton.
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    K Number
    K032840
    Device Name
    ATRION MEDICAL QL INFLATION DEVICE
    Manufacturer
    ATRION MEDICAL PRODUCTS, INC.
    Date Cleared
    2004-03-03

    (174 days)

    Product Code
    KOE
    Regulation Number
    876.5520
    Why did this record match?
    Product Code :

    KOE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Inflation Device is recommended for use with balloon dilatation catheters to create and monitor the pressure in the balloon and to deflate the balloon.
    Device Description
    The Athor Modiour & Locking palm grip that control that control the plunger, a manometer to measure pressure and a connecting tube.
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    K Number
    K972964
    Device Name
    ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE
    Manufacturer
    ATRION MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-10-10

    (60 days)

    Product Code
    KOE
    Regulation Number
    876.5520
    Why did this record match?
    Product Code :

    KOE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The inflation device is intended for single use while performing gastrointestinal (GI), gastrouterine (GU) and lacrimal duct balloon catheter dilation procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.
    Device Description
    The Atrion Medical Balloon Catheter Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that control the plunger. a manometer to measure pressure and a connecting tube. The Device has a fluid capacity of 20 cc and an operating pressure range of vacuum to between 10 and 20 atm, depending on the manometer attached.
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    K Number
    K962611
    Device Name
    BARD EAGLE INFLATION DEVICE
    Manufacturer
    RYDER INTL. CORP.
    Date Cleared
    1996-10-21

    (110 days)

    Product Code
    KOE
    Regulation Number
    876.5520
    Why did this record match?
    Product Code :

    KOE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The inflation device is intended for single use while performing urological balloon dilation procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.
    Device Description
    The Ryder Urological Balloon Catheter Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that control the plunger, a manometer to measure pressure and a high pressure connecting tube. The Device has a fluid capacity of 20 cc and an operating pressure range of vacuum to 20 atm.
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    K Number
    K961904
    Device Name
    AQ HYDROPHILIC DILATORS
    Manufacturer
    COOK UROLOGICAL, INC.
    Date Cleared
    1996-10-18

    (155 days)

    Product Code
    KOE
    Regulation Number
    876.5520
    Why did this record match?
    Product Code :

    KOE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AQ Hydrophilic Dilators are intended to dilate the suprapubic and/or nepluostomy fascial tract, urethra and ureters.
    Device Description
    The AQ Hydrophilic Dilators are intended to dilate the suprapubic and/or nepluostomy fascial tract, urethra and ureters. The constructions of the materials are polyethylcuse and vinyl. The lydrophilic coating will allow the catheters to become lubricious which will reduce friction.
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