K231539
- 510(k) number
- K231539
- Device name
- pRESET LITE Thrombectomy Device
- Applicant
- Phenox Limited IE
- Product code
- POL — Neurovascular Mechanical Thrombectomy Device For Acu
- Decision date
- 2023-10-21
- Date received
- 2023-05-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K231539.pdf
Official FDA record: K231539
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.