K233505
- 510(k) number
- K233505
- Device name
- Sapphire ULTRA Coronary Dilatation Catheter
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd. CN
- Product code
- LOX — Catheters, Transluminal Coronary Angioplasty, Percut
- Decision date
- 2024-08-15
- Date received
- 2023-10-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K233505.pdf
Official FDA record: K233505
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.