K252569
- 510(k) number
- K252569
- Device name
- Carrier XL Delivery Catheter
- Applicant
- Balt USA, LLC CA · US
- Product code
- QJP — Catheter, Percutaneous, Neurovasculature
- Decision date
- 2025-10-22
- Date received
- 2025-08-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K252569.pdf
Official FDA record: K252569
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.