510(k) K252441
K252441 is an FDA 510(k) premarket notification submitted by South53, LLC for the device "Primero Safe Access System". The FDA issued a decision of Substantially Equivalent on Sep 29, 2025. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 29, 2025
- Date Received
- Aug 4, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type