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FDA 510(k) Application Details - K151145
Device Classification Name
Catheter, Peripheral, Atherectomy
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510(K) Number
K151145
Device Name
Catheter, Peripheral, Atherectomy
Applicant
Volcano AtheroMed, Inc.
1455 Adams Drive, Suite 1120
Menlo Park, CA 94025 US
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Contact
JEAN CHANG
Other 510(k) Applications for this Contact
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
04/29/2015
Decision Date
05/26/2015
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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