The following data is part of a premarket notification filed by Acutus Medical, Inc. with the FDA for Acqcross Qx Integrated Transseptal Dilator/needle.
| Device ID | K220047 |
| 510k Number | K220047 |
| Device Name: | AcQCross Qx Integrated Transseptal Dilator/Needle |
| Classification | Introducer, Catheter |
| Applicant | Acutus Medical, Inc. 2210 Faraday Ave, Suite 100 Carlsbad, CA 92008 |
| Contact | Sarah Clay |
| 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 | 2022-01-05 |
| Decision Date | 2022-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850027837611 | K220047 | 000 |
| 00850027837598 | K220047 | 000 |
| 00850027837574 | K220047 | 000 |
| 00850027837550 | K220047 | 000 |