510(k) clearance
JADE SCORE PTA Scoring Balloon Dilatation Catheter
- 510(k) number
- K261778
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd.
- Decision date
- Sep 16, 2026
- Date received
- May 29, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PNO
- Device type
- Catheter, Percutaneous, Cutting/Scoring
- Device class
- Class II
- Regulation
- 21 CFR 870.1250
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Shenzhen, CN