AcQGuide MAX Steerable Sheath

Catheter, Steerable

Acutus Medical, Inc.

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

Pre-market Notification Details

Device IDK211100
510k NumberK211100
Device Name:AcQGuide MAX Steerable Sheath
ClassificationCatheter, Steerable
Applicant Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad,  CA  92008
ContactSerena Sanginthirath
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDRA  
CFR Regulation Number870.1280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-04-13
Decision Date2021-05-14

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