K260091
- 510(k) number
- K260091
- Device name
- Aventus Introducer Sheath
- Applicant
- Inquis Medical CA · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2026-04-13
- Date received
- 2026-01-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K260091.pdf
Official FDA record: K260091
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.