K253590
- 510(k) number
- K253590
- Device name
- Millipede System
- Applicant
- Perfuze, Ltd. IE
- Product code
- NRY — Catheter, Thrombus Retriever
- Decision date
- 2026-03-16
- Date received
- 2025-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253590.pdf
Official FDA record: K253590
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.