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510(k) Data Aggregation

    K Number
    K022167
    Device Name
    PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM
    Manufacturer
    PALL CORP.
    Date Cleared
    2003-03-07

    (247 days)

    Product Code
    CAC
    Regulation Number
    868.5830
    Why did this record match?
    Applicant Name (Manufacturer) :

    PALL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System is indicated for the post-operative collection of blood from an orthopedic surgerv patient's wounds and body cavities, filtration of that blood, and reinfusion of the blood into the same patient. Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System significantly reduces lipids, leucocytes, and C3a from the blood before reinfusing it.
    Device Description
    The DONOR. HemoVac, Orthofusor, Solocotrans, and ConstaVac are intended to be use to collect, filter, and reinfuse blood lost by the patient due to surgery.
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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?
    Applicant Name (Manufacturer) :

    PALL CORP.

    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
    K980762
    Device Name
    PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE
    Manufacturer
    PALL CORP.
    Date Cleared
    1998-09-01

    (186 days)

    Product Code
    DTM
    Regulation Number
    870.4260
    Why did this record match?
    Applicant Name (Manufacturer) :

    PALL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pall STAT-PRIMe Blood Filter for Extracorporcal Service is indicated for use in cardiopulmonary bypass procedures for the removal of microemboli in the arterial return line.
    Device Description
    Pall Stat-Prime D Blood Filter for Extracorporeal Service (Featuring the Duroflo® Treatment)
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