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510(k) Data Aggregation
K Number
K233277Device Name
Filter Needle for Single Use
Manufacturer
Hangzhou Qiantang Longyue Biotechnology Co., LTD
Date Cleared
2024-05-10
(224 days)
Product Code
FPB
Regulation Number
880.5440Why did this record match?
Product Code :
FPB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is intended for the aspiration and preparation of medical fluid, not including injection.
Device Description
The Filter Needle for Single Use is a single use, irradiation sterilized device that is designed to be used for use in conjunction with luer taper infusion sets conforming to EN ISO 80369-7 for the extraction, filtration and configuration of medicinal solutions and is not intended for injection purposes. Filter Needle for Single Use consists of cap, needle cannula, needle hub, sheath and filter. The cap, needle hub and sheath are made of polycarbonate (PC), the needle tube is made of medical stainless steel (SUS304), and filter is made of polyamide (PA).
The needle holder is a 6% standard tapered connector with good connectivity to the infusion apparatus.
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K Number
K143583Device Name
Cathivex ¿GV filter units
Manufacturer
MERCK MILLIPORE LTD.
Date Cleared
2015-08-11
(236 days)
Product Code
FPB
Regulation Number
880.5440Why did this record match?
Product Code :
FPB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cathivex®-GV filter units are in-line 0.22um, sterilizing-grade filters for use with intravenously administered aqueous solutions. The filters remove particulates, microbial contamination, and air bubbles in applications where venting and low protein binding membranes are required or desired.
Device Description
Cathivex®-GV filter units are sterile, non-pyrogenic, single-use filter devices intended for sterile filtration of aqueous solutions for intravenous infusions. Cathivex®-GV filter units are designed with a Female Luer Lok™ inlet and a Male Luer Lok™ outlet. Cathivex®-GV filter units contain a 0.22um Durapore® hydrophilic filter membrane constructed from polyvinylidene fluoride (PVDF) and a 0.03um hydrophobic vent membrane constructed from polytetrafluoroethylene (PTFE). The filter membrane is designed to remove particles, microorganisms, microprecipitates and undissolved powders which are larger than 0.22 um. The vent membrane is designed to prevent air locks and air emboli by automatically venting air introduced upstream. The filter housing material is molded from PVC.
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K Number
K113227Device Name
NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
Manufacturer
BAXTER HEALTHCARE CORP.
Date Cleared
2011-12-08
(37 days)
Product Code
FPB
Regulation Number
880.5440Why did this record match?
Product Code :
FPB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The I.V. extension set with a 0.22 micron air venting filter is indicated for the administration of fluid to a patient's vascular system and for the removal of air and particulate matter.
Device Description
The MICRO-VOLUME Extension Set product line consists of sterile, single use disposable devices indicated for the administration of fluid to a patient's vascular system and for the removal of air and particulate matter. These intravascular administration sets provide a clinician the ability to increase the distance between the patient and the fluid administration source. The overall set configuration consists of a female Luer connector, non-DEHP microbore tubing, a 0.22 micron hydrophilic filter, and a male Luer lock connector at the distal end of the set. The filter housing also contains a 0.1 micron hydrophobic filter which vents air to the atmosphere. The MICRO-VOLUME Extension Set with a 0.22 micron filter is designed to remove air and particulate matter and has a maximum pressure of 45 psi (2241 kPa). The product is sterile and non-pyrogenic.
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K Number
K021293Device Name
ARTERIA BLOOD FILTER
Manufacturer
ARTERIA MEDICAL SCIENCE, INC.
Date Cleared
2002-08-22
(121 days)
Product Code
FPB
Regulation Number
880.5440Why did this record match?
Product Code :
FPB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ArteriA Blood Filter is intended for use as an accessory in the administration of blood, blood components or solutions into a patient's vascular system through a venous access device.
Device Description
The ArteriA Blood Filter device is a blood transfusion filter and drip chamber connected to flexible medical grade tubing having a connector on each end. The input side to the dripchamber/filter has a three-way stopcock valve that has both a male and female Luer connections available for use. The outlet of the drip-chamber/filter has a male Luer connector that facilitates connection to a venous access device such as a catheter or sheath. It may also be connected to another stopcock.
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K Number
K993379Device Name
PALL SUPOR AEF FILTER
Manufacturer
PALL CORP.
Date Cleared
1999-12-16
(70 days)
Product Code
FPB
Regulation Number
880.5440Why did this record match?
Product Code :
FPB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Removal by in-line filtration of inadvertent contaminants (including bacteria, particulates, and entrained air) from infused intravenous fluids.
Device Description
Not Found
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K Number
K974661Device Name
0.2 U BACTERIAL FILTER
Manufacturer
SIMS DELTEC, INC.
Date Cleared
1998-02-11
(58 days)
Product Code
FPB
Regulation Number
880.5440Why did this record match?
Product Code :
FPB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 0.2 µ Bacterial Filter can be used with administration sets or extension sets for removal of particulate matter during the administration of fluids or medications.
Device Description
The purpose of this submission is to offer an 0.2 u Bacterial Filter with standard luer connections for use with administration sets or extension sets used with fluid delivery devices. The subject device is intended to be "added-on" to an administration set or extension set.
The filter is an air-eliminating filter and is circular in shape with a center vent. The inlet of the filter is a standard female luer and the outlet of the filter is a standard male luer. The filter membranes are enclosed within a plastic case which is approximately 1.22 in. (width) x 1.85 in. (length).
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K Number
K964283Device Name
AUTOPRIME
Manufacturer
ARBOR TECHNOLOGIES, INC.
Date Cleared
1997-01-22
(86 days)
Product Code
FPB
Regulation Number
880.5440Why did this record match?
Product Code :
FPB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Per FDA Safety Alert: Hazards of Precipitation Associated with Parental Nutrition, issued April 18, 1994, an IV filter is indicated for use when infusing either central or peripheral parenteral nutrition admixtures. Both pore sizes of filters are being offered. a 0.22um air eliminating filter for nonligid containing admixtures, and a 1.2um air eliminating filter for lipid containing admixtures.
Device Description
Not Found
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K Number
K954331Device Name
PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)
Manufacturer
PALL BIOMEDICAL PRODUCTS CO.
Date Cleared
1997-01-09
(482 days)
Product Code
FPB
Regulation Number
880.5440Why did this record match?
Product Code :
FPB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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