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FDA 510(k) Application Details - K161171
Device Classification Name
Transducer, Pressure, Catheter Tip
More FDA Info for this Device
510(K) Number
K161171
Device Name
Transducer, Pressure, Catheter Tip
Applicant
ST. JUDE MEDICAL INC.
5050 NATHAN LANE NORTH
PLYMOUTH, MN 55442 US
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Contact
HUDA YUSUF
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Regulation Number
870.2870
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Classification Product Code
DXO
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More FDA Info for this Product Code
Date Received
04/26/2016
Decision Date
08/15/2016
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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