K251051
- 510(k) number
- K251051
- Device name
- AuST Steerable Sheath
- Applicant
- CenterPoint Systems, LLC UT · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2025-04-30
- Date received
- 2025-04-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K251051.pdf
Official FDA record: K251051
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.