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FDA 510(k) Application Details - K192106
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K192106
Device Name
Introducer, Catheter
Applicant
Acutus Medical, Inc.
2210 Faraday Ave., Suite 100
Carlsbad, CA 92008 US
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Contact
Serena Sanginthirath
Other 510(k) Applications for this Contact
Regulation Number
870.1340
More FDA Info for this Regulation Number
Classification Product Code
DYB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/05/2019
Decision Date
09/03/2019
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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