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510(k) Data Aggregation

    K Number
    K023673
    Device Name
    AIRLIFE DEMAND NASAL CANNULA
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Date Cleared
    2003-05-02

    (182 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLEGIANCE HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is an adjunct to oxygen therapy with its primary functions being that of a conduit for the delivery of intermittent oxygen upon demand to a patient's lungs and to transmit a patient's breath effort to the oxygen conserver. Oxygen is administered only during the inhalation cycle, conserving oxygen during the exhalation cycle.
    Device Description
    Airlife Demand Nasal Cannula
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    K Number
    K023419
    Device Name
    TRILAMINATE DRAPES/TIBURON
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Date Cleared
    2003-02-11

    (123 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLEGIANCE HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Convertors®Trilaminate Drapes are devices intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
    Device Description
    These drapes will be comprised of an outer and inner layer of polyolefin-based nonwovens with an inner layer of polyolefin-based film. Several drapes will also have clear polyethylene side panels on either end of the drapes.
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    K Number
    K024120
    Device Name
    MODIFICATION TO TEMNO BIOPSY NEEDLES
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Date Cleared
    2003-01-15

    (30 days)

    Product Code
    FCG
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLEGIANCE HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Semi-Automated Temno® Biopsy Device is a system used for tissue sampling from several different organs, including, but not limited to, the Kidney, Liver, Breast and Prostate. This biopsy device is used to remove, by cutting, a specimen of tissue for microscopic evaluation.
    Device Description
    Needles are permanently attached to an automated device comprised of a spring that activates a stylet and cannula in a specified cutting sequence. The needle cuts and traps the tissue samples, which are substantially equivalent to samples obtained with similar devices currently in the market.
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    K Number
    K024292
    Device Name
    MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Date Cleared
    2003-01-09

    (16 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLEGIANCE HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This latex glove contains 50 micrograms or less of total water extractable protein per gram. In addition, this glove has been tested for use with chemotherapy drugs.
    Device Description
    Positive Touch Powder Free Examination Gloves With Protein and Chemotherapy Labeling Claim are formulated using latex and are coated with a Polymer coating. These gloves are offered non-sterile in sizes X-small, Small, Medium, Large and X-large.
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    K Number
    K024102
    Device Name
    DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Date Cleared
    2002-12-18

    (6 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLEGIANCE HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Dental Powder-Free Latex Examination Gloves are formulated using natural rubber latex and offered non-sterile.
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    K Number
    K023425
    Device Name
    DRAPES WITH ABSORBENT REINFORCEMENT
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Date Cleared
    2002-11-06

    (26 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLEGIANCE HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Convertors®Surgical Drapes are devices made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
    Device Description
    The drapes are comprised of a base layer of nonwoven material to which the absorbent reinforcement structure is laminated.
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    K Number
    K022765
    Device Name
    NITRILE POWDER-FREE EXAMINATION GLOVES
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Date Cleared
    2002-10-11

    (52 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLEGIANCE HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.
    Device Description
    Nitrile Powder-Free Examination Gloves are formulated using nitrile and offered powder-free.
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    K Number
    K023170
    Device Name
    NITRILE POWDER-FREE EXAMINATION GLOVES
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Date Cleared
    2002-10-09

    (16 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLEGIANCE HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Nitrile Powder-Free Examination Gloves are formulated using nitrile and offered powder-free.
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    K Number
    K023167
    Device Name
    BREATHABLE SURGICAL GOWN
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Date Cleared
    2002-10-02

    (9 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLEGIANCE HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Convertors®Breathable Surgical Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms. body fluids and particulate material.
    Device Description
    The Breathable Surgical Gown consists of an outer and inner layer of spunmelt polyolefin nonwoven fabric with a middle layer of breathable monolithic film throughout the entire gown. The Breathable Sleeve Surgical Gown consists of sleeves containing a an outer and inner layer of spunmelt polyolefin nonwoven fabric with a middle layer of breathable monolithic film with a gown body comprised of spunmelt nonwoven (SMS) with a polyolefin-based film reinforcement.
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    K Number
    K012931
    Device Name
    GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Date Cleared
    2002-08-20

    (354 days)

    Product Code
    FRG
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLEGIANCE HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A sterilization container system is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. This container system is intended to be used in STERRAD® 50, STERRAD® 100 and STERRAD® 100S, ethylene oxide and pre-vacuum sterilization processes.
    Device Description
    The Allegiance Genesis™ STERRAD® Compatible Reusable Sterilization Container System is a reusable device which features an assortment of container designs and sizes, and inner basket and platform types.
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