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FDA 510(k) Application Details - K131063
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K131063
Device Name
Catheter, Percutaneous
Applicant
ST. JUDE MEDICAL
5050 NATHAN LANE NORTH
PLYMOUTH, MN 55442 US
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Contact
HEATHER TAYLOR
Other 510(k) Applications for this Contact
Regulation Number
870.1250
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Classification Product Code
DQY
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More FDA Info for this Product Code
Date Received
04/16/2013
Decision Date
08/15/2013
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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