K232458
- 510(k) number
- K232458
- Device name
- JETiHydrodynamic Thrombectomy System
- Applicant
- ABBOTT MEDICAL CA · US
- Product code
- QEZ — Aspiration Thrombectomy Catheter
- Decision date
- 2023-12-19
- Date received
- 2023-08-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K232458.pdf
Official FDA record: K232458
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.