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510(k) Data Aggregation
K Number
K970225Device Name
ALPHA MICRON 20/40 MICROAGGREGATE FILTER
Manufacturer
ALPHA THERAPEUTIC CORP.
Date Cleared
1997-02-14
(28 days)
Product Code
CAK
Regulation Number
880.5440Why 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.
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K Number
K955515Device Name
ALPHA MICRON 20 MICROAGGREGATE FILTER
Manufacturer
ALPHA THERAPEUTIC CORP.
Date Cleared
1996-02-12
(70 days)
Product Code
CAK
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
ALPHA THERAPEUTIC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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