Cleared Traditional

AcQGuide? VUE Steerable Sheath

K221044 · Acutus Medical, Inc. · Cardiovascular
May 2022
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K221044 is an FDA 510(k) clearance for the AcQGuide? VUE 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 5, 2022, 27 days after receiving the submission on April 8, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1280.

Submission Details

510(k) Number K221044 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 2022
Decision Date May 05, 2022
Days to Decision 27 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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