510(k) K252116 · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Firefighter Pro PTCA Balloon Catheter
| Applicant | Shanghai MicroPort Medical (Group) Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Apr 7, 2026 |
| Received | Jul 7, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252116
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.