510(k) K192864 ยท QEY Mechanical Thrombolysis Catheter
UNI*FUSE Infusion System with Cooper Wire
| Applicant | AngioDynamics, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Jun 1, 2020 |
| Received | Oct 7, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192864
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.