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FDA 510(k) Application Details - K160827
Device Classification Name
Catheter, Peripheral, Atherectomy
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510(K) Number
K160827
Device Name
Catheter, Peripheral, Atherectomy
Applicant
AVINGER, INC.
400 CHESAPEAKE DRIVE
REDWOOD CITY, CA 94063 US
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Contact
Golnaz Moeini
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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
03/25/2016
Decision Date
04/21/2016
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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