The following data is part of a premarket notification filed by Acutus Medical, Inc. with the FDA for Acqref Introducer Sheath.
| Device ID | K192106 |
| 510k Number | K192106 |
| Device Name: | AcQRef Introducer Sheath |
| Classification | Introducer, Catheter |
| Applicant | Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 |
| Contact | Serena Sanginthirath |
| Correspondent | Serena Sanginthirath Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-05 |
| Decision Date | 2019-09-03 |
| Summary: | summary |