510(k) K233505 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Sapphire ULTRA Coronary Dilatation Catheter
| Applicant | OrbusNeich Medical (Shenzhen) Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Aug 15, 2024 |
| Received | Oct 31, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233505
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.