K254178
- 510(k) number
- K254178
- Device name
- SAYA 86 Radial Access Guide Catheter
- Applicant
- Asahi Intecc Co., Ltd. JP
- Product code
- QJP — Catheter, Percutaneous, Neurovasculature
- Decision date
- 2026-05-11
- Date received
- 2025-12-23
- 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: K254178.pdf
Official FDA record: K254178
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.