K253652
- 510(k) number
- K253652
- Device name
- Genie MAX Large Bore Introducer Sheath
- Applicant
- Cultiv8 1, LLC MN · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2026-01-22
- Date received
- 2025-11-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K253652.pdf
Official FDA record: K253652
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.