K251014
- 510(k) number
- K251014
- Device name
- APRO 45 Catheter
- Applicant
- Alembic, LLC CA · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2025-05-01
- Date received
- 2025-04-02
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K251014.pdf
Official FDA record: K251014
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.