K201341 is an FDA 510(k) clearance for the AcQMap 3D Imaging and Mapping Catheter. This device is classified as 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 September 15, 2020, 118 days after receiving the submission on May 20, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220.
| 510(k) Number | K201341 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2020 |
| Decision Date | September 15, 2020 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MTD — Catheter, Intracardiac Mapping, High-density Array |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1220 |