510(k) K033698 ยท JXG Shunt, Central Nervous System And Components
CONTOUR-FLEX VALVE AND SHUNT SYSTEM
| Applicant | Integra Neurosciences Implants S.A., Planisboro NJ, US |
| Decision | Substantially Equivalent, Dec 17, 2003 |
| Received | Nov 25, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033698
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2016 | Integra LifeSciences Corp. Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a cardboard box.
Silicone elastomer Ventricular Cat Terminated |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.