Cleared Traditional

AcQRef Introducer Sheath

K171557 · Acutus Medical, Inc. · Cardiovascular
Feb 2018
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K171557 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 February 6, 2018, 252 days after receiving the submission on May 30, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K171557 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2017
Decision Date February 06, 2018
Days to Decision 252 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