K252441
- 510(k) number
- K252441
- Device name
- Primero Safe Access System
- Applicant
- South53, LLC CA · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2025-09-29
- Date received
- 2025-08-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K252441.pdf
Official FDA record: K252441
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.