Cleared Traditional

AcQMap 3D Imaging and Mapping Catheter, Model 900009

K210766 · Acutus Medical, Inc. · Cardiovascular
Jun 2022
Decision
463d
Days
Class 2
Risk

About This 510(k) Submission

K210766 is an FDA 510(k) clearance for the AcQMap 3D Imaging and Mapping Catheter, Model 900009, a Catheter, Intracardiac Mapping, High-density Array (Class II — Special Controls, product code MTD), submitted by Acutus Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on June 21, 2022, 463 days after receiving the submission on March 15, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number K210766 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2021
Decision Date June 21, 2022
Days to Decision 463 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MTD — Catheter, Intracardiac Mapping, High-density Array
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1220

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