K233646
- 510(k) number
- K233646
- Device name
- Intri24 Introducer Sheath (52-101)
- Applicant
- Inari Medical, Inc. CA · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2023-12-12
- Date received
- 2023-11-14
- 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: K233646.pdf
Official FDA record: K233646
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.