K170819 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 October 16, 2017, 210 days after receiving the submission on March 20, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220.
| 510(k) Number | K170819 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2017 |
| Decision Date | October 16, 2017 |
| Days to Decision | 210 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 |