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FDA 510(k) Application Details - K143316
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K143316
Device Name
Wire, Guide, Catheter
Applicant
Medtronic, Inc.
8200 Coral Sea Street NE
Mounds View, MN 55112 US
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Contact
Mia Hunt
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
DQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/19/2014
Decision Date
03/11/2015
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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