K250958
- 510(k) number
- K250958
- Device name
- APRO 55 Swift Catheter and Alembic Aspiration Tubing
- Applicant
- Alembic, LLC CA · US
- Product code
- NRY — Catheter, Thrombus Retriever
- Decision date
- 2025-04-28
- Date received
- 2025-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250958.pdf
Official FDA record: K250958
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.