AcQGuide® VUE 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® Vue Steerable Sheath.

Pre-market Notification Details

Device IDK221044
510k NumberK221044
Device Name:AcQGuide® VUE Steerable Sheath
ClassificationCatheter, Steerable
Applicant Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad,  CA  92008
ContactSarah Clay
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDRA  
CFR Regulation Number870.1280 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedYes
Combination ProductNo
Date Received2022-04-08
Decision Date2022-05-05

Trademark Results [AcQGuide]

Mark Image

Registration | Serial
Application Date
87246283 5308281 Live/Registered
Acutus Medical, Inc.

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