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510(k) Data Aggregation

    K Number
    K222852
    Device Name
    Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle
    Manufacturer
    Nipro Medical Corporation
    Date Cleared
    2023-05-25

    (246 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nipro Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nipro SafeTouch Needle is indicated for general purpose injection of fluid from vials, and to and from parts of the body below the surface of the skin. It includes a needle shield to prevent against accidental needlestick injuries. The needle is compatible with standard Luer-lock syringes. The Nipro Syringe with SafeTouch Needle is indicated for general purpose injection of fluid from vials, and to and from parts of the body below the surface of the skin. It includes a needle shield to prevent against accidental needlestick injuries.
    Device Description
    The Nipro SafeTouch Needle is a disposable hypodermic single lumen needle with attached safety device. The safety device is a needle shield that covers the needle post treatment eliminating accidental needlestick injuries. It is provided with and without a piston syringe. The Nipro SafeTouch Needle is available in gauges of 18-30, lengths of ½". The needles are available individually or attached to a luer lock syringe in volumes of 1, 3, 5 and 10mL. The device is sterile, single use only, non-toxic, and non-pyrogenic. It is sterilized by Ethylene Oxide gas and has a shelf-life of 5 years.
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    K Number
    K212677
    Device Name
    aboNT SYRINGE
    Manufacturer
    Nipro Medical Corporation
    Date Cleared
    2022-04-15

    (234 days)

    Product Code
    FMF, FMI
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nipro Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for intramuscular administration of Dysport® for the temporary improvement of moderate to severe glabellar lines in adults <65 years of age.
    Device Description
    The aboNT Syringe is a piston syringe with needle consisting of graduated barrel, plunger rod, and gasket. It is provided with a permanently attached hypodermic needle that is 31G x 5/16″. The syringe barrel is 0.3 mL in volume, with a graduated scale labeled in both volumetric (mL) and corresponding unit dosing for Dysport® (60 units/0.3mL). The syringe is sterile, single use only, non-toxic, non-pyrogenic and sterilized by E-beam radiation. The shelf-life has been determined to be 5 years.
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    K Number
    K190037
    Device Name
    Cronus HP PTA Balloon Catheter
    Manufacturer
    Nipro Medical Corporation
    Date Cleared
    2019-10-24

    (289 days)

    Product Code
    LIT
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nipro Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cronus HP PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the following vessel areas: - Femoral arteries - Popliteal arteries - Iliac arteries - Renal arteries - For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. These catheters are not intended for use in coronary arteries or the neurovasculature.
    Device Description
    The Cronus™ HP PTA Balloon Catheter is intended for PTA (Percutaneous Transluminal Angioplasty) procedures. It is an over the wire (OTW) 0.035" dual lumen catheter with a distally mounted semi- compliant inflatable balloon and a flush cut tip. The catheter manifold includes two lumens. A y-connector adaptation is located at the proximal part of the catheter and provides access to the two different lumens. The lumen marked "GW" is the central lumen of the catheter which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.035 inches. The lumen, marked "BALLOON" is used to inflate and deflate the dilatation balloon with a solution of contrast medium and saline. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The balloon segment expands to a known diameter at a specific inflation pressure. The Cronus™ HP PTA Balloon Catheter is sterilized using ethylene oxide gas and satisfies a minimum Sterility Assurance Level (S.A.L.) of 10 °. Shelf-life is determined to be 4 years. The device is available in multiple configurations ranging in sizes of balloon diameter 4-10mm, balloon lengths 20-80mm, and catheter lengths of 45 and 80cm
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    K Number
    K191359
    Device Name
    Nipro Syringe
    Manufacturer
    Nipro Medical Corporation
    Date Cleared
    2019-10-09

    (141 days)

    Product Code
    FMF, FMI
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nipro Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To inject fluids into or withdraw fluids from the body.
    Device Description
    The NIPRO Syringe is a piston syringe consisting of graduated barrel, plunger rod, and gasket. It is provided in luer slip, luer lock and eccentric luer slip tips, with and without attached hypodermic needles are available in ranges of 20-27G, and 3/8 to 1 ½" in length. Gauges are color coded for easy differentiation. Its function is mechanical. The syringe is sterile, single use only, non-toxic, non-pyrogenic and sterilized by Ebeam radiation. The shelf-life has been determined to be 5 years.
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    K Number
    K182940
    Device Name
    Surdial DX Hemodialysis System
    Manufacturer
    Nipro Medical Corporation
    Date Cleared
    2019-07-19

    (269 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nipro Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SURDIAL DX Hemodialysis System is indicated for implementing hemodialysis treatments in patients with acute and chronic kidney (renal) failure. The system can be used in hospitals, healthcare facilities and outpatient dialysis centers when prescribed by a physician and used by qualified operators. The SURDIAL DX accommodates the use of both low flux and high flux hemodialysis.
    Device Description
    The SURDIAL DX Hemodialysis System is a single patient dialysis unit that incorporates the mechanism of mixing and producing of dialysate by quantitative mixing method and the mechanism of ultrafiltration control by use of a piston pump. The SURDIAL DX consists of 4 sections: Panel operating section, Blood circuit control section, Liquid circuit control section and Power source control section. CAN communication is used for communication between each section.
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    K Number
    K173029
    Device Name
    Nipro Syringe
    Manufacturer
    Nipro Medical Corporation
    Date Cleared
    2018-03-30

    (183 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nipro Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    to inject fluids into or withdraw fluids from the body
    Device Description
    The NIPRO Syringe is a piston syringe consisting of graduated barrel, plunger rod, and gasket. It is provided in luer slip, luer lock and eccentric luer slip tips, with and without attached hypodermic needles are available in ranges of 20-25G, and 3/8 to 1 ½" in length. Gauges are color coded for easy differentiation. Its function is mechanical. The syringe is sterile, single use only, non-toxic, non-pyrogenic and sterilized by Ebeam radiation. The shelf-life has been determined to be 5 years. This device is not intended for patients less than 2 years of age.
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    K Number
    K161681
    Device Name
    Nipro SafeTouch IV Catheter
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Date Cleared
    2017-03-08

    (264 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    NIPRO MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nipro SafeTouch IV Catheter is a passive anti-needle stick intra-vascular catheter that is inserted into the patient's vascular system for short term use for the infusion of fluids, and/or blood components. 16-24 gauge catheters may be used with power injectors for which the maximum pressure setting is 300psi
    Device Description
    Nipro SafeTouch IV Catheter consists of an over-the-needle, catheter made of radiopaque polyurethane with a passive safety mechanism that will engage upon removal from the patient in order to prevent accidental needlestick injuries. The device is available in gauges 16-24 and in catheter lengths of ¾" – 2". It is also available with or without wings on the hub. Gauges are color coded for easy differentiation. Nipro SafeTouch IV Catheter is sterilized by Ethylene Oxide gas (EtO). It is packaged in a peel blister that ensures the sterility of the device until package is opened and labeled for single use only. A sleeve of SafeTouch Cath contains 5 units of blister packages. An inner box contains 10 sleeves (50 units). An outer box contains 40 inner boxes (3000 units). Its shelf life period is 5 years.
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    K Number
    K160444
    Device Name
    FB-U Hemodialyzer
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Date Cleared
    2017-02-08

    (357 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    NIPRO MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hemodialysis with the FB-U Hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
    Device Description
    The Nipro FB-U hemodialyzer is a medical device intended for use as an artificial kidney system for the treatment of patients with renal failure. During treatment, blood is circulated from the patient, through the extracorporeal system, into the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate.
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    K Number
    K151141
    Device Name
    Cronus HP - High Pressure Peripheral Balloon Catheter
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Date Cleared
    2016-01-14

    (260 days)

    Product Code
    LIT
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    NIPRO MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cronus HP - High Pressure Peripheral Balloon Catheted for Percutaneous Transluminal Angioplasty in the following vessel areas: - Femoral arteries - Popliteal arteries - Iliac arteries - Renal arteries - For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. These catheters are not intended for use in coronary arteries or the neurovasculature.
    Device Description
    The Cronus HP - High Pressure Peripheral Balloon Catheter is intended for PTA (Percutaneous Transluminal Angioplasty) procedures. It is an over the wire (OTW) 0.035" dual lumen catheter with a distally mounted semi- compliant inflatable balloon and a flush cut tip. The catheter manifold includes two lumens. A y-connector adaptation is located at the proximal part of the catheter and provides access to the two different lumens. The lumen marked "GW" is the central lumen of the catheter which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.035 inches. The lumen, marked "BALLOON" is used to inflate and deflate the dilatation balloon with a solution of contrast medium and saline. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The balloon segment expands to a known diameter at a specific inflation pressure.
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    K Number
    K140191
    Device Name
    ELISIO-H HEMODIALYZER
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Date Cleared
    2014-04-14

    (77 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    NIPRO MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hemodialysis with an ELISIO™-H hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs. The device is for prescription use only. This product is intended for single use only. The performance properties of reused dialyzers have not been established.
    Device Description
    The ELISIO-H hemodialyzers are medical devices used as an artificial kidney system for the treatment of patients with renal failure. During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The ELISIO-H dialyzers are composed of polyethersulfone fiber and are available in various sizes, which are differentiated by membrane surface area.
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