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510(k) Data Aggregation

    K Number
    K072299
    Device Name
    POWRSYRINGE ASPIRATOR
    Manufacturer
    PINYONS MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2007-10-04

    (48 days)

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

    PINYONS MEDICAL TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PowrSyringe Aspirator is a piston syringe to inject fluids into, or aspirate fluids from, the body.
    Device Description
    The PowrSyringe Aspirator is a single use manual hand-held general-purpose piston syringe with handles to inject fluids into, or aspirate fluid from. The PowrSyringe Aspirator handles allow the user to pull the plunger back within the barrel when the user squeezes the handles. Users may open the PowrSyringe Aspirator's handles to inject fluids back into the barrel. The PowrSyringe Aspirator safety features include: - Clear barrel for visualization of air bubbles. - Minimum dead space between the plunger and barrel with the handles are fully squeezed. - Handle design to prevent the plunger from being pulled out of the barrel during aspiration.
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    K Number
    K072318
    Device Name
    POWRSYRINGE INJECTOR
    Manufacturer
    PINYONS MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2007-09-21

    (32 days)

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

    PINYONS MEDICAL TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PowrSyringe Injector is a piston syringe to inject fluids into, or aspirate fluids from, the body including use in angiography.
    Device Description
    The PowrSyringe Injector is a single use manual hand-held piston syringe with handles to inject fluids into, or aspirate fluid from, the body including use in angiography. The PowrSyringe Injector handles allow the user to push the blunger into the barrel when the user squeezes the handles. Users may open the PowrSyringe Injector's handles to aspirate fluid back into the barrel. The PowrSyringe Injector safety features include: - Clear barrel for visualization of air bubbles. a - I Minimum dead space between the plunger and barrel with the handles are fully squeezed. - 트 Handle design to prevent the plunger from being pulled out of the barrel during aspiration.
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    K Number
    K072345
    Device Name
    POWRSYRINGE MONITOR
    Manufacturer
    PINYONS MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2007-09-21

    (31 days)

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

    PINYONS MEDICAL TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PowrSyringe Monitor is a piston syringe to inject fluids and monitor the pressure of that fluid including use in inflation and discography.
    Device Description
    The PowrSyringe Monitor is a single use manual hand-held piston syringe with handles and a pressure gauge to inject fluids and monitor the pressure of that fluid including use in inflation and discography. The PowrSyringe Monitor handles allow the user to push the plunger into the barrel when the user squeezes the handles. Users may open the PowrSyringe Monitor's handles to aspirate fluid back into the barrel. The PowrSyringe Monitor safety features include: - Clear barrel for visualization of air bubbles. - Minimum dead space between the plunger and barrel with the handles are fully squeezed. - Handle design to prevent the plunger from being pulled out of the barrel during aspiration.
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