K242676
- 510(k) number
- K242676
- Device name
- pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
- Applicant
- Phenox Limited IE
- Product code
- POL — Neurovascular Mechanical Thrombectomy Device For Acu
- Decision date
- 2025-02-28
- Date received
- 2024-09-06
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242676.pdf
Official FDA record: K242676
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.