AcQRef Introducer Sheath

Introducer, Catheter

Acutus Medical, Inc.

The following data is part of a premarket notification filed by Acutus Medical, Inc. with the FDA for Acqref Introducer Sheath.

Pre-market Notification Details

Device IDK192106
510k NumberK192106
Device Name:AcQRef Introducer Sheath
ClassificationIntroducer, Catheter
Applicant Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad,  CA  92008
ContactSerena Sanginthirath
CorrespondentSerena Sanginthirath
Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad,  CA  92008
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-05
Decision Date2019-09-03
Summary:summary

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