K261610
- 510(k) number
- K261610
- Device name
- Verge Microcatheter
- Applicant
- Instylla, Inc. MA · US
- Product code
- KRA — Catheter, Continuous Flush
- Decision date
- 2026-06-11
- Date received
- 2026-05-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K261610.pdf
Official FDA record: K261610
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.