Cleared Traditional

AcQGuide MAX Steerable Sheath

K211100 · Acutus Medical, Inc. · Cardiovascular
May 2021
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K211100 is an FDA 510(k) clearance for the AcQGuide MAX 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 May 14, 2021, 31 days after receiving the submission on April 13, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1280.

Submission Details

510(k) Number K211100 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2021
Decision Date May 14, 2021
Days to Decision 31 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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