Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K970225
    Device Name
    ALPHA MICRON 20/40 MICROAGGREGATE FILTER
    Manufacturer
    ALPHA THERAPEUTIC CORP.
    Date Cleared
    1997-02-14

    (28 days)

    Product Code
    CAK
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALPHA THERAPEUTIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Alpha Micron®-20/40 Microaggregate Filter is for filtering microaggregate debris from plasma derivative products to prevent pulmonary embolization.
    Device Description
    The Alpha Micron®-20/40 Microaggregate Filter is a filter used for the filtration of microaggregate debris from plasma derivative products in order to aid in the prevention of pulmonary embolization. The device is designed to be utilized in either of two applications; by syringe, or by administration set. The syringe is inserted into the exposed inlet of the filter while the spike end is inserted into the bottle (or bag) of the plasma derivative. The blood plasma derivative is aspirated through the filter into the syringe resulting in filtration. The administration set is placed into the exposed inlet of the filter while the spike end is attached to an infusion set. The plasma derivative is drawn through the filter during administration resulting in filtration.
    Ask a Question
    K Number
    K955515
    Device Name
    ALPHA MICRON 20 MICROAGGREGATE FILTER
    Manufacturer
    ALPHA THERAPEUTIC CORP.
    Date Cleared
    1996-02-12

    (70 days)

    Product Code
    CAK
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALPHA THERAPEUTIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1