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510(k) Data Aggregation
K Number
K112525Device Name
D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS
Manufacturer
PAREXELINTERNATIONAL
Date Cleared
2011-09-29
(29 days)
Product Code
DTM
Regulation Number
870.4260Why did this record match?
Applicant Name (Manufacturer) :
PAREXELINTERNATIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The D731 MICRO Ph.I.S.I.O. with 27 micron screen with phosphoryIcholine coating and the D733 MICRO Ph.I.S.I.O. with 40 micron screen with phosphoryIcholine coating are recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filters are used to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.
Device Description
The D731/D733 MICRO Ph.I.S.I.O. Arterial Filters are sterile, non-pyrogenic disposable filter for use in the arterial line of the cardiopulmonary bypass circuit with flow rate not exceeding 6.0 liters/minute. The D731/D733 MICRO Ph.I.S.I.O. are Arterial Filters with 27 and 40 micron filters screen, respectively. The devices are designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris, greater than the pore size, from the arterial line perfusate.
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