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510(k) K112525

D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS by Parexel International — Product Code DTM

K112525 is an FDA 510(k) premarket notification submitted by Parexel International for the device "D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS". The FDA issued a decision of Substantially Equivalent on September 29, 2011. The device falls under product code DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line), a Class II device regulated under 21 CFR 870.4260.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2011
Date Received
August 31, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class
Class II
Regulation Number
870.4260
Review Panel
CV
Submission Type

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FDA data resources