K260606
- 510(k) number
- K260606
- Device name
- Echo Large Bore Introducer Sheath
- Applicant
- Echo Medical, LLC CA · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2026-04-29
- Date received
- 2026-02-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K260606.pdf
Official FDA record: K260606
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.