K250012
- 510(k) number
- K250012
- Device name
- Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
- Applicant
- Perfuze, Ltd. IE
- Product code
- NRY — Catheter, Thrombus Retriever
- Decision date
- 2025-02-26
- Date received
- 2025-01-02
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250012.pdf
Official FDA record: K250012
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.