K253361
- 510(k) number
- K253361
- Device name
- Teleport Glide Microcatheter
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd. CN
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2026-04-10
- Date received
- 2025-09-30
- 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: K253361.pdf
Official FDA record: K253361
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.