The following data is part of a premarket notification filed by Acutus Medical, Inc. with the FDA for Acqguide Flex With Acqcross Qx, Acqguide Mini With Acqcross Qx.
| Device ID | K193509 |
| 510k Number | K193509 |
| Device Name: | AcQGuide Flex With AcQCross QX, AcQGuide Mini With AcQCross QX |
| Classification | Introducer, Catheter |
| Applicant | Acutus Medical, Inc. 2210 Faraday Ave, Suite 100 Carlsbad, CA 92008 |
| Contact | Greg Geissinger |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-12-18 |
| Decision Date | 2020-01-17 |