K243549
- 510(k) number
- K243549
- Device name
- JETi Hydrodynamic Thrombectomy System
- Applicant
- ABBOTT MEDICAL CA · US
- Product code
- QEZ — Aspiration Thrombectomy Catheter
- Decision date
- 2025-04-04
- Date received
- 2024-11-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243549.pdf
Official FDA record: K243549
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.