The following data is part of a premarket notification filed by Acutus Medical, Inc. with the FDA for Acqguide Max Steerable Sheath.
| Device ID | K211100 |
| 510k Number | K211100 |
| Device Name: | AcQGuide MAX Steerable Sheath |
| Classification | Catheter, Steerable |
| Applicant | Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 |
| Contact | Serena Sanginthirath |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-04-13 |
| Decision Date | 2021-05-14 |