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510(k) K193509

AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX by Acutus Medical, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2020
Date Received
December 18, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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