K241025
- 510(k) number
- K241025
- Device name
- JADE PLUS PTA Balloon Dilatation Catheter
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd. CN
- Product code
- LIT — Catheter, Angioplasty, Peripheral, Transluminal
- Decision date
- 2024-06-11
- Date received
- 2024-04-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K241025.pdf
Official FDA record: K241025
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.