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FDA 510(k) Application Details - K170792
Device Classification Name
Catheter, Peripheral, Atherectomy
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510(K) Number
K170792
Device Name
Catheter, Peripheral, Atherectomy
Applicant
Cardiovascular Systems, Inc.
1225 Old Highway 8 NW
Saint Paul, MN 55112 US
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Contact
Kara Cutshall
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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
03/16/2017
Decision Date
06/09/2017
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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