The following data is part of a premarket notification filed by Acutus Medical, Inc. with the FDA for Acqmap 3d Imaging And Mapping Catheter.
| Device ID | K201341 |
| 510k Number | K201341 |
| Device Name: | AcQMap 3D Imaging And Mapping Catheter |
| Classification | Catheter, Intracardiac Mapping, High-density Array |
| Applicant | Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 |
| Contact | Karla Schaffner |
| Correspondent | Karla Schaffner Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 |
| Product Code | MTD |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-20 |
| Decision Date | 2020-09-15 |