K262391
- 510(k) number
- K262391
- Device name
- APRO 35 Swift Catheter and Alembic Aspiration Tubing
- Applicant
- Alembic, LLC CA · US
- Product code
- NRY — Catheter, Thrombus Retriever
- Decision date
- 2026-08-12
- Date received
- 2026-07-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K262391.pdf
Official FDA record: K262391
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.