K260559
- 510(k) number
- K260559
- Device name
- NHanceIT
- Applicant
- IMDS Operation B.V. NL
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2026-08-14
- Date received
- 2026-02-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K260559.pdf
Official FDA record: K260559
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.