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510(k) Data Aggregation
K Number
K980994Device Name
IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES
Manufacturer
VENETEC INTL., INC.
Date Cleared
1998-05-29
(73 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
VENETEC INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An intravascular administration set with needle access to be used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vessel.
Device Description
IV Extension/Administration Sets with Needle
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K Number
K980992Device Name
IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES
Manufacturer
VENETEC INTL., INC.
Date Cleared
1998-05-28
(72 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
VENETEC INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An extension set to be used as an extension to the Intravascular administration set to be assul in the IV extension set will connect the administration set to a catheter or needle inserted into a vessel. The IV IV administration bet to a calleless access devices to protect the users from needle stick injuries.
Device Description
Not Found
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