Cleared Traditional

AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX

K193509 · Acutus Medical, Inc. · Cardiovascular
Jan 2020
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K193509 is an FDA 510(k) clearance for the AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Acutus Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on January 17, 2020, 30 days after receiving the submission on December 18, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K193509 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2019
Decision Date January 17, 2020
Days to Decision 30 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340