K243297
- 510(k) number
- K243297
- Device name
- APRO 70 Swift Catheter
- Applicant
- Alembic, LLC CA · US
- Product code
- QJP — Catheter, Percutaneous, Neurovasculature
- Decision date
- 2025-01-14
- Date received
- 2024-10-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243297.pdf
Official FDA record: K243297
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.