Cleared Traditional

AcQCross Qx Integrated Transseptal Dilator/Needle

K220047 · Acutus Medical, Inc. · Cardiovascular
Feb 2022
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K220047 is an FDA 510(k) clearance for the AcQCross Qx Integrated Transseptal Dilator/Needle, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Acutus Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 8, 2022, 34 days after receiving the submission on January 5, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K220047 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 2022
Decision Date February 08, 2022
Days to Decision 34 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