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510(k) Data Aggregation

    K Number
    K243322
    Device Name
    Altaviz Intravitreal Syringe
    Manufacturer
    Altaviz, LLC
    Date Cleared
    2025-05-09

    (198 days)

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

    Altaviz, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Altaviz Intravitreal Syringe is intended for use by heath care professionals for general purpose fluid aspiration/injection. It is indicated for general and intravitreal use in adult patients.
    Device Description
    The Altaviz Intravitreal Syringe is a three-piece sterile, single use, hypodermic syringe with male 6% (Luer) conical lock fittings, which are connectable to a compatible female 6% (Luer) connector. The syringe assembly consists of a lubricated polycarbonate barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The barrel scale of the Altaviz Intravitreal Syringe incorporates a scale graduated in units of milliliters and is provided sterile by an irradiation sterilization method. The only difference between the Altaviz Intravitreal Syringe and the BD 1mL Luer-Lok Syringe is that the Altaviz Intravitreal Syringe is routinely tested to, and must meet, additional requirements to support intraocular use including endotoxin and particulate matter. The Altaviz Intravitreal Syringe is provided sterile by irradiation sterilization.
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    K Number
    K231261
    Device Name
    Altaviz Needle Kit II
    Manufacturer
    Altaviz, LLC
    Date Cleared
    2023-07-27

    (87 days)

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

    Altaviz, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Altaviz Needle Kit II is a convenience kit that includes: A 29G injection needle that is a sterile medical device for single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Either an 18G or a 19G 5 micron filter needle that is a sterile medical device for single use intended to draw up fluids into a syringe. The Altaviz Needle Kit II is indicated for intravitreal use.
    Device Description
    The Altaviz Needle Kit II is a convenience kit with a tray that is made of polyethylene terephthalate glycol (PETG) and a coated paper lid. The original version of this kit, the Altaviz Needle Kit, was cleared on December 5, 2022 (K222681), and the only difference between the Altaviz Needle Kit and the Altaviz Needle Kit II is the 29G injection needle included. The tray of the Altaviz Needle Kit II is designed to securely store two separately packaged and previously sterilized needles: a single-use 29G injection needle and either a sterile 18G or 19G 5 micron filter needle. The tray lid provides protection and helps secure the needles during transport. No changes to the primary packaging of the needles or additional sterilization occurs prior to inclusion in the Altaviz Needle Kit II. The 29G needle is a sterile hypodermic single lumen needle, for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polycarbonate designed to be connected with a male connector (nozzle) of a piston syringe. The 18G or 19G 5 micron filter needle is a sterile medical device for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polycarbonate or ABS (respectively) designed to be connected with a male connector (nozzle) of a piston syringe. The filter needle is used to draw up fluids into a syringe.
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    K Number
    K222681
    Device Name
    Altaviz Needle Kit
    Manufacturer
    Altaviz, LLC
    Date Cleared
    2022-12-05

    (90 days)

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

    Altaviz, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Altaviz Needle Kit is a convenience kit that includes: A 29G injection needle that is a sterile medical device for single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Either an 18G or a 19G 5 micron filter needle that is a sterile medical device for single use intended to draw up fluids into a syringe. The Altaviz Needle Kit is indicated for intravitreal use.
    Device Description
    The Altaviz Needle Kit is a convenience kit with a tray that is made of polyethylene terephthalate glycol (PETG) and a coated paper lid. The tray is designed to securely store two separately packaged and previously sterilized needles: a single-use 29G injection needle and either a sterile 18G or 19G 5 micron filter needle. The tray lid provides protection and helps secure the needles during transport. No changes to the primary packaging of the needles or additional sterilization occurs prior to inclusion in the Altaviz Needle Kit. The 29G needle is a sterile hypodermic single lumen needle, for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a piston syringe. The 18G or 19G 5 micron filter needle is a sterile medical device for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polycarbonate or ABS (respectively) designed to be connected with a male connector (nozzle) of a piston syringe. The filter needle is used to draw up fluids into a syringe.
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