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510(k) Data Aggregation

    K Number
    K060643
    Device Name
    QL LOCKING SYRINGE
    Manufacturer
    ATRION MEDICAL PRODUCTS, INC.
    Date Cleared
    2006-07-12

    (124 days)

    Product Code
    MAV
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATRION MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atrion Medical QL® Locking Syringe Device is intended for single use to inject fluid into and aspirate fluid from a balloon interventional device having a recommended balloon inflation volume.
    Device Description
    The Atrion Medical QL® Locking Syringe Device consists of a plastic syringe with a screw-type plunger and a locking mechanism.
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    K Number
    K043249
    Device Name
    ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE
    Manufacturer
    ATRION MEDICAL PRODUCTS, INC.
    Date Cleared
    2005-05-25

    (183 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATRION MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeedleVISE™ Large-Bore Sharps Securing Device is intended for use in various clinical procedures as a sharps securing device for contaminated needles that do not have integral engineered sharps safety systems.
    Device Description
    The NeedleVISE™ Large-Bore Sharps Securing Device is a single patient procedure use, disposable device used for securing needles. The healthcare professional using only one hand can render the sharps harmless. The purpose of the NeedleVISE™ Large-Bore Sharps Securing Device is to provide a means to make contaminated sharps immediately unavailable for all instances in which introduction of contaminated sharps containers is not acceptable.
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    K Number
    K041158
    Device Name
    ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM
    Manufacturer
    ATRION MEDICAL PRODUCTS, INC.
    Date Cleared
    2004-06-16

    (44 days)

    Product Code
    CAZ
    Regulation Number
    868.5140
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATRION MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atrion Epidural Anesthesia Kit is intended for use in the administration of anesthetic agents into the epidural space. It is recommended that the epidural catheter be removed or replaced every 72 hours. The NeedleVISE™ sharps securing system is intended for use in sterile anesthesiology procedure trays as a sharps securing device for the contaminated specialized needles that do not have integral engineered sharps safety devices.
    Device Description
    The Atrion Epidural Anesthesia Kit with NeedleVISE™ Sharps Securing System consists of components necessary for conducting repeated administration of anesthetic agents in the epidural space. The kit also contains the NeedleVISE™ sharps securing system which is a opidural opade, single patient procedure use, disposable device used for securing the specialized needles found in sterile anesthesiology procedural trays. As provided to the user, the NeedleV/SE™ sharps securing system is retained in an upright position in the sterile procedure tray to allow for stability and one-hand insertion of sharps during a procedure. The healthcare professional using only one hand can render the sharps harmless while remaining with the patient in the sterile field. The purpose of the NeedleVISE™ sharps while rounsvitem is to provide a means to make engineered sharps control protection available within the sterile field, for all instances in which introduction of contaminated sharps containers is not acceptable.
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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?
    Applicant Name (Manufacturer) :

    ATRION MEDICAL PRODUCTS, INC.

    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
    K020333
    Device Name
    ATRION MEDICAL QL FLUID DISPENSING SYRINGE
    Manufacturer
    ATRION MEDICAL PRODUCTS, INC.
    Date Cleared
    2002-04-25

    (84 days)

    Product Code
    DXT
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATRION MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The syringe is intended for single use by healthcare professionals to dispense fluids to the body and monitor the pressure of those fluids.
    Device Description
    The Atrion Medical QL™ Fluid Dispensing Syringe 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.
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    K Number
    K973633
    Device Name
    ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET
    Manufacturer
    ATRION MEDICAL PRODUCTS, INC.
    Date Cleared
    1998-01-16

    (183 days)

    Product Code
    OKS
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATRION MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atrion Medical Coated Lacrimal Intubation Set is valuable in the reconstruction of the lacrimal outflow system and also useful in canaliculus repair, lacrimal obstruction and complicated and uncomplicated dacryocystorhinostomy procedures. Indications For Use: 1. Maintenance of lacrimal outflow post primary DCR surgical procedures. 2. Maintenance of lacrimal outflow post failed open DCR surgical procedures with complete obstruction. 3. Reconstruction of the canaliculi.
    Device Description
    The Atrion Medical Coated Lacrimal Intubation Set consists of two malleable stainless steel probes (to facilitate insertion) securely attached to a flexible coated silicone tube of varying thickness. The intubation set is a single-use product, sterilized by radiation.
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    K Number
    K973872
    Device Name
    ATRION MEDICAL COATED LACRIMAL INTUBATION SET
    Manufacturer
    ATRION MEDICAL PRODUCTS, INC.
    Date Cleared
    1998-01-08

    (90 days)

    Product Code
    OKS
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATRION MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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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?
    Applicant Name (Manufacturer) :

    ATRION MEDICAL PRODUCTS, INC.

    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
    K971100
    Device Name
    ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR
    Manufacturer
    ATRION MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-05-23

    (58 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATRION MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atrion Medical Autogenous Tissue Collector is useful in the collection of bone or other tissue for reconstruction, implants and repair procedures, for collection of tissue for pathological analysis and for retrieving root tips and precious metals.
    Device Description
    The Atrion Medical Autogenous Tissue Collector consists of a screen, a gasket, screen support, plastic cover and elastomer tube. The device is a single-use product, sterilized by gamma or E-Beam irradiation.
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