The following data is part of a premarket notification filed by Dib Ultranav Medical, Llc with the FDA for Dib Ultranav Transseptal Catheter System.
| Device ID | K213492 |
| 510k Number | K213492 |
| Device Name: | Dib UltraNav Transseptal Catheter System |
| Classification | Introducer, Catheter |
| Applicant | Dib UltraNav Medical, LLC 123 W. Mills Avenue STE 600 El Paso, TX 79901 |
| Contact | Lowry Barfield |
| Correspondent | Noelle Sutton The Tamarack Group – MPLS, LLC 2584 Upton Avenue South Minneapolis, MN 55405 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-01 |
| Decision Date | 2022-03-24 |