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510(k) Data Aggregation

    K Number
    K233277
    Device 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
    880.5440
    Why 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
    K143583
    Device Name
    Cathivex ¿GV filter units
    Manufacturer
    MERCK MILLIPORE LTD.
    Date Cleared
    2015-08-11

    (236 days)

    Product Code
    FPB
    Regulation Number
    880.5440
    Why 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
    K113227
    Device 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
    880.5440
    Why 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
    K021293
    Device Name
    ARTERIA BLOOD FILTER
    Manufacturer
    ARTERIA MEDICAL SCIENCE, INC.
    Date Cleared
    2002-08-22

    (121 days)

    Product Code
    FPB
    Regulation Number
    880.5440
    Why 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
    K993379
    Device Name
    PALL SUPOR AEF FILTER
    Manufacturer
    PALL CORP.
    Date Cleared
    1999-12-16

    (70 days)

    Product Code
    FPB
    Regulation Number
    880.5440
    Why 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
    K974661
    Device Name
    0.2 U BACTERIAL FILTER
    Manufacturer
    SIMS DELTEC, INC.
    Date Cleared
    1998-02-11

    (58 days)

    Product Code
    FPB
    Regulation Number
    880.5440
    Why 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
    K964283
    Device Name
    AUTOPRIME
    Manufacturer
    ARBOR TECHNOLOGIES, INC.
    Date Cleared
    1997-01-22

    (86 days)

    Product Code
    FPB
    Regulation Number
    880.5440
    Why 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
    K954331
    Device 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
    880.5440
    Why did this record match?
    Product Code :

    FPB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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