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510(k) Data Aggregation
K Number
K981547Device Name
NFC NEEDLEFREE Y-SITE, MODEL 69970
Manufacturer
FILTERTEK, INC.
Date Cleared
1998-06-18
(49 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
FILTERTEK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NFC Y-Site is for single patient use and intended for placement between the male Luer connection of a primary solution source and the patient's vascular access device. In this position, the y-site body provides unobstructed flow between the fluid source and the patient. The Needlefree side port of the y-site is swabbable and can be accessed multiple times using a male Luer for the purpose of administering general IV solutions or blood.
Device Description
The Filtertek NFC Needlefree Y-Site is intended for single patient use and intended for placement between the male Luer connection of a primary solution source and the patient's vascular access device. In this position, the y-site body provides unobstructed flow between the fluid source and the patient. The needlefree side port of the y-site can be swabbed and then accessed multiple times. The closure system has been tested and has been found to maintain line patency throughout the labeled duration of use.
The Filtertek NFC Needlefree Y-Site is a sterile, non-pyrogenic component packaged in a Twek/polyethylene form, fill, and seal package. The materials used to manufacture the Filtertek NFC Needlefree Y-Site have been tested per tripartite guidelines and are safe for their intended use.
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K Number
K981548Device Name
NFC NEEDLEFREE CONNECTOR MODEL 69900
Manufacturer
FILTERTEK, INC.
Date Cleared
1998-06-18
(49 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
FILTERTEK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to be used as a needless injection port that can be attre hed to any standard luer connector. It is a single patient use device that has an access port that can be swabbed and accessed multiple times.
Device Description
The Filtertek NFC Needlefree Connector is a one-piece design. luer interfacing injection port. It is sterile, nonpyroqenic and packaged in a Tyvek/polyethylene form, fill, and seal package. The materials used to manufacture the Filtertek NFC Needlefree Connector have been tested per tripartite guidelines and are safe for their intended use.
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