510(k) K261778 ยท PNO Catheter, Percutaneous, Cutting/Scoring
JADE SCORE PTA Scoring Balloon Dilatation Catheter
| Applicant | OrbusNeich Medical (Shenzhen) Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Sep 16, 2026 |
| Received | May 29, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261778
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.