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FDA 510(k) Application Details - K162326
Device Classification Name
Catheter, Peripheral, Atherectomy
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510(K) Number
K162326
Device Name
Catheter, Peripheral, Atherectomy
Applicant
Avinger, Inc
400 Chesapeake Drive
Redwood City, CA 94063 US
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Contact
Patty Hevey
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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
08/19/2016
Decision Date
10/18/2016
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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