510(k) K032817 ยท JXG Shunt, Central Nervous System And Components
EXTERNAL DRAINAGE SET
| Applicant | Integra Neurosciences Implants S.A., Planisboro NJ, US |
| Decision | Substantially Equivalent, Oct 6, 2003 |
| Received | Sep 10, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032817
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2016 | Integra LifeSciences Corp. Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. External drainag system is primary pa Terminated |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.