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510(k) Data Aggregation
K Number
K060643Device Name
QL LOCKING SYRINGE
Manufacturer
ATRION MEDICAL PRODUCTS, INC.
Date Cleared
2006-07-12
(124 days)
Product Code
MAV
Regulation Number
870.1650Why 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
K043249Device 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
880.5570Why 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
K041158Device 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
868.5140Why 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
K032840Device Name
ATRION MEDICAL QL INFLATION DEVICE
Manufacturer
ATRION MEDICAL PRODUCTS, INC.
Date Cleared
2004-03-03
(174 days)
Product Code
KOE
Regulation Number
876.5520Why 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
K020333Device Name
ATRION MEDICAL QL FLUID DISPENSING SYRINGE
Manufacturer
ATRION MEDICAL PRODUCTS, INC.
Date Cleared
2002-04-25
(84 days)
Product Code
DXT
Regulation Number
870.1650Why 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
K973633Device 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/AWhy 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
K973872Device 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/AWhy 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
K972964Device Name
ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE
Manufacturer
ATRION MEDICAL PRODUCTS, INC.
Date Cleared
1997-10-10
(60 days)
Product Code
KOE
Regulation Number
876.5520Why 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
K971100Device Name
ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR
Manufacturer
ATRION MEDICAL PRODUCTS, INC.
Date Cleared
1997-05-23
(58 days)
Product Code
EIA
Regulation Number
872.6640Why 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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