K261492
- 510(k) number
- K261492
- Device name
- FieldFlex Steerable Sheath
- Applicant
- CenterPoint Systems, LLC UT · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2026-06-05
- Date received
- 2026-05-06
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K261492.pdf
Official FDA record: K261492
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.