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FDA 510(k) Application Details - K210911
Device Classification Name
More FDA Info for this Device
510(K) Number
K210911
Device Name
WOLF Thrombectomy System, 14F
Applicant
DeVoro Medical, Inc.
46724 Lakeview Blvd
Fremont, CA 94538 US
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Contact
Michael P Wallace
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Regulation Number
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Classification Product Code
QEW
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Date Received
03/29/2021
Decision Date
10/19/2021
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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