510(k) K260686 ยท PNO Catheter, Percutaneous, Cutting/Scoring
Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter
| Applicant | Zylox Medtech Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Oct 22, 2026 |
| Received | Mar 3, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260686
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.