K260751
- 510(k) number
- K260751
- Device name
- 35 Helix Guidewire
- Applicant
- Piraeus Medical, Inc. MN · US
- Product code
- MOF — Guide, Wire, Catheter, Neurovasculature
- Decision date
- 2026-08-27
- Date received
- 2026-03-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260751.pdf
Official FDA record: K260751
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.