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510(k) Data Aggregation
K Number
K994429Device Name
VENUSA, LTD. EXTENSION SET WITH FILTER
Manufacturer
Date Cleared
2000-03-03
(64 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
VENUSA LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Venusa, Ltd. Extension Set with Filter is used for IV fluid administration where The Velusa, Do. Dxtention Dot, Mai 22 mirron is desired. Use of the device helps assure the delivery of a bacteria-free product. The device is used in conjunction with an IV administration set and in-dwelling IV catheter.
Device Description
The device consists of female Luer lock, TOTM (non-DEHP) plasticised PVC tubing, a Millipore 0.22 micron air eliminating filter, an on\off clamp, and a male Luer lock adapter.
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K Number
K981683Device Name
HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y
Manufacturer
Date Cleared
1998-07-28
(76 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
VENUSA LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Venusa, Ltd. Huber Needle Infusion Set is intended to be used access an implanted port for the purpose of delivering drugs and solutions.
The Venusa, Ltd. Huber Needle Infusion Set is intended to be used to deliver solutions and drugs into vascular implant ports.
Device Description
The device consists of female Luer lock adapter, Non-DEHP PVC tubing, an onloff clamp, 314 stainless steel Huber point non-coring needle bent to 90 degrees. The device includes a winged hub that surrounds the needle to aid in the insertion, securement, and removal of the device.
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