510(k) K251318 ยท QEY Mechanical Thrombolysis Catheter
VariFuse Adjustable Infusion Catheter
| Applicant | Argon Medical Devices, Inc., Athens TX, US |
| Decision | Substantially Equivalent, Jan 20, 2026 |
| Received | Apr 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251318
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.