K251044
- 510(k) number
- K251044
- Device name
- 93 NeuFlex Catheter
- Applicant
- Piraeus Medical MN · US
- Product code
- QJP — Catheter, Percutaneous, Neurovasculature
- Decision date
- 2025-05-23
- Date received
- 2025-04-03
- 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: K251044.pdf
Official FDA record: K251044
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.