K231608
- 510(k) number
- K231608
- Device name
- Teleport XT Microcatheter
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd. CN
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2024-01-07
- Date received
- 2023-06-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K231608.pdf
Official FDA record: K231608
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.