510(k) K924600 ยท JXG Shunt, Central Nervous System And Components
INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETS
| Applicant | Cordis Corp., Miami Lakes FL, US |
| Decision | Substantially Equivalent, Dec 10, 1992 |
| Received | Sep 11, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924600
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2016 | Integra LifeSciences Corp. Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. Internal drainage set is primary pack Terminated |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.