K250305
- 510(k) number
- K250305
- Device name
- Reprocessed Agilis NxT Steerable Introducer
- Applicant
- Innovative Health AZ · US
- Product code
- PNE — Reprocessed Catheter Introducer
- Decision date
- 2026-01-07
- Date received
- 2025-02-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250305.pdf
Official FDA record: K250305
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.