K260929
- 510(k) number
- K260929
- Device name
- Neonav ECG Tip Location System
- Applicant
- Navi Medical Technologies AU
- Product code
- LJS — Catheter, Intravascular, Therapeutic, Long-Term Grea
- Decision date
- 2026-04-17
- Date received
- 2026-03-20
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260929.pdf
Official FDA record: K260929
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.