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FDA 510(k) Application Details - K172167
Device Classification Name
Catheter, Thrombus Retriever
More FDA Info for this Device
510(K) Number
K172167
Device Name
Catheter, Thrombus Retriever
Applicant
InNeuroCo, Inc.
4635 NW 103rd Avenue
Sunrise, FL 33351 US
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Contact
Marc Litzenberg
Other 510(k) Applications for this Contact
Regulation Number
870.1250
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Classification Product Code
NRY
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More FDA Info for this Product Code
Date Received
07/18/2017
Decision Date
04/19/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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