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510(k) K100646

AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE by Medtronic, Inc. — Product Code DTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2010
Date Received
March 5, 2010
Clearance Type
Traditional
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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Other clearances for product code DTM

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  • K112525 — D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS (September 29, 2011)
  • K093986 — AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS (January 22, 2010)
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