Cleared Special

AcQRef Introducer Sheath

K192106 · Acutus Medical, Inc. · Cardiovascular
Sep 2019
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K192106 is an FDA 510(k) clearance for the AcQRef Introducer Sheath, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Acutus Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on September 3, 2019, 29 days after receiving the submission on August 5, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K192106 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2019
Decision Date September 03, 2019
Days to Decision 29 days
Submission Type Special
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