K260626
- 510(k) number
- K260626
- Device name
- Multiflex Steerable Sheath 17.5F
- Applicant
- Vizaramed, Inc. CA · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2026-03-26
- Date received
- 2026-02-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K260626.pdf
Official FDA record: K260626
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.