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FDA 510(k) Application Details - K112917
Device Classification Name
Catheter, Percutaneous
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510(K) Number
K112917
Device Name
Catheter, Percutaneous
Applicant
MEDTRONIC, INC.
8200 CORAL SEA STREET
MS MVS11
MOUNDS VIEW, MN 55112 US
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Contact
DEBORAH KIDDER
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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
10/03/2011
Decision Date
10/27/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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