510(k) K192289 ยท JXG Shunt, Central Nervous System And Components
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
| Applicant | Irras USA, Ltd., San Diego CA, US |
| Decision | Substantially Equivalent, Nov 15, 2019 |
| Received | Aug 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192289
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.