510(k) K254212 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
NC PTA Balloon Dilatation Catheter
| Applicant | Kossel Medtech (Suzhou) Co., Ltd., Suzhou New District, CN |
| Decision | Substantially Equivalent, Sep 16, 2026 |
| Received | Dec 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254212
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.