K254223
- 510(k) number
- K254223
- Device name
- Next Generation 088 Catheter
- Applicant
- Balt USA, LLC CA · US
- Product code
- QJP — Catheter, Percutaneous, Neurovasculature
- Decision date
- 2026-04-16
- Date received
- 2025-12-29
- 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: K254223.pdf
Official FDA record: K254223
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.