K240397
- 510(k) number
- K240397
- Device name
- AlphaVac MMA F1885 System (H787253020)
- Applicant
- AngioDynamics, Inc. NY · US
- Product code
- QEZ — Aspiration Thrombectomy Catheter
- Decision date
- 2024-04-01
- Date received
- 2024-02-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K240397.pdf
Official FDA record: K240397
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.