K261808
- 510(k) number
- K261808
- Device name
- ISAAC Neurovascular Navigation Catheter
- Applicant
- Microvention Inc. d/b/a Terumo Neuro CA · US
- Product code
- QJP — Catheter, Percutaneous, Neurovasculature
- Decision date
- 2026-06-30
- Date received
- 2026-06-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K261808.pdf
Official FDA record: K261808
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.