Cleared Traditional

AcQCross Qx Integrated Transseptal Dilator/Needle

K210685 · Acutus Medical, Inc. · Cardiovascular
Apr 2021
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K210685 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 April 6, 2021, 29 days after receiving the submission on March 8, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K210685 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 2021
Decision Date April 06, 2021
Days to Decision 29 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