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FDA 510(k) Application Details - K141801
Device Classification Name
Catheter, Peripheral, Atherectomy
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510(K) Number
K141801
Device Name
Catheter, Peripheral, Atherectomy
Applicant
COVIDIEN, LLC
3033 CAMPUS DRIVE
PLYMOUTH, MN 55442 US
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Contact
JULIE UNDERDAHL
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Regulation Number
870.4875
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Classification Product Code
MCW
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More FDA Info for this Product Code
Date Received
07/03/2014
Decision Date
10/16/2014
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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