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FDA 510(k) Application Details - K110389
Device Classification Name
Catheter, Peripheral, Atherectomy
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510(K) Number
K110389
Device Name
Catheter, Peripheral, Atherectomy
Applicant
CARDIOVASCULAR SYSTEMS, INC.
651 CAMPUS DR
SAINT PAUL, MN 55112 US
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Contact
MEGAN M BRANDT
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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
02/10/2011
Decision Date
03/11/2011
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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