K252508
- 510(k) number
- K252508
- Device name
- Intri26 Introducer Sheath
- Applicant
- Inari Medical, Inc. CA · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2025-12-17
- Date received
- 2025-08-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252508.pdf
Official FDA record: K252508
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.