K250314
- 510(k) number
- K250314
- Device name
- Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
- Applicant
- Surgical Instrument Service and Savings, Inc. OR · US
- Product code
- PNE — Reprocessed Catheter Introducer
- Decision date
- 2025-12-19
- Date received
- 2025-02-04
- 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: K250314.pdf
Official FDA record: K250314
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.