510(k) K260416 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
ZYLOX Hippo PTA Balloon Dilatation Catheter
| Applicant | Zylox Medtech Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Sep 21, 2026 |
| Received | Feb 9, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260416
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.