K251357
- 510(k) number
- K251357
- Device name
- Esperance pHLO Aspiration System
- Applicant
- Phenox, Ltd. IE
- Product code
- NRY — Catheter, Thrombus Retriever
- Decision date
- 2026-01-15
- Date received
- 2025-04-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251357.pdf
Official FDA record: K251357
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.