510(k) K200807 ยท JXG Shunt, Central Nervous System And Components
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
| Applicant | Irras USA, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 29, 2020 |
| Received | Mar 27, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200807
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.