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FDA 510(k) Application Details - K131452
Device Classification Name
Transducer, Pressure, Catheter Tip
More FDA Info for this Device
510(K) Number
K131452
Device Name
Transducer, Pressure, Catheter Tip
Applicant
ST. JUDE MEDICAL SYSTEMS AB
4 ROBBINS RD.
WESTFORD, MA 01886 US
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Contact
ERDULFO DE PERALTA
Other 510(k) Applications for this Contact
Regulation Number
870.2870
More FDA Info for this Regulation Number
Classification Product Code
DXO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/20/2013
Decision Date
09/05/2013
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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