Cleared Traditional

AcQGuide Steerable Sheath

K162925 · Acutus Medical, Inc. · Cardiovascular
Apr 2017
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K162925 is an FDA 510(k) clearance for the AcQGuide Steerable Sheath, a Catheter, Steerable (Class II — Special Controls, product code DRA), submitted by Acutus Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on April 6, 2017, 169 days after receiving the submission on October 19, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1280.

Submission Details

510(k) Number K162925 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 2016
Decision Date April 06, 2017
Days to Decision 169 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRA — Catheter, Steerable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1280

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