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FDA 510(k) Application Details - K071253
Device Classification Name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
More FDA Info for this Device
510(K) Number
K071253
Device Name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Applicant
MEDTRONIC VASCULAR
7611 NORTHLAND DR.
MINNEAPOLIS, MN 55428 US
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Contact
JESSICA SIXBERRY
Other 510(k) Applications for this Contact
Regulation Number
870.4260
More FDA Info for this Regulation Number
Classification Product Code
DTM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/04/2007
Decision Date
07/03/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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