AcQGuide Flex With AcQCross QX, AcQGuide Mini With AcQCross QX

Introducer, Catheter

Acutus Medical, Inc.

The following data is part of a premarket notification filed by Acutus Medical, Inc. with the FDA for Acqguide Flex With Acqcross Qx, Acqguide Mini With Acqcross Qx.

Pre-market Notification Details

Device IDK193509
510k NumberK193509
Device Name:AcQGuide Flex With AcQCross QX, AcQGuide Mini With AcQCross QX
ClassificationIntroducer, Catheter
Applicant Acutus Medical, Inc. 2210 Faraday Ave, Suite 100 Carlsbad,  CA  92008
ContactGreg Geissinger
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2019-12-18
Decision Date2020-01-17

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