K243287
- 510(k) number
- K243287
- Device name
- APRO 70 Swift Catheter and Alembic Aspiration Tubing
- Applicant
- Alembic, LLC CA · US
- Product code
- NRY — Catheter, Thrombus Retriever
- Decision date
- 2025-02-24
- Date received
- 2024-10-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243287.pdf
Official FDA record: K243287
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.