510(k) K760501 ยท JXG Shunt, Central Nervous System And Components
VALVE, STANDARD MODEL PUDENZE FLUSHING
| Applicant | Heyer Schulte Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 30, 1976 |
| Received | Aug 23, 1976 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K760501
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2012 | Integra LifeSciences Corp Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of hydrocephalic patients when shunting cerebrospina Terminated |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.