510(k) K904883 ยท JXG Shunt, Central Nervous System And Components
OPTYX
| Applicant | Baxter Healthcare Corp, Irvine CA, US |
| Decision | Substantially Equivalent, Jul 24, 1991 |
| Received | Oct 26, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904883
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2009 | Integra Neuro Sciences Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit NL950-V and Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit with Ventricular Drainage System NL9 Terminated |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.