K252441 is an FDA 510(k) clearance for the Primero Safe Access System. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by South53, LLC (San Juan Capistrano, US). The FDA issued a Cleared decision on September 29, 2025, 56 days after receiving the submission on August 4, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K252441 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2025 |
| Decision Date | September 29, 2025 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB - Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |