510(k) K853361 ยท JXG Shunt, Central Nervous System And Components
H-H VENTRICULAR CATHETERS & RESERVOIRS
| Applicant | Holter-Hausner Intl., Bridgeport PA, US |
| Decision | Substantially Equivalent, Aug 28, 1985 |
| Received | Aug 12, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853361
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2006 | Vygon Neuro 6 cm Catheter Reservoir with 10 cm extension Terminated |
HCA | None listed |
| Jan 10, 2006 | Vygon Neuro 7 cm Catheter Reservoir with 10 cm extension Terminated |
HCA | None listed |
| Jan 10, 2006 | Vygon Neuro 10 cm Scopable Catheter Reservoir Terminated |
HCA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.