510(k) K855058 ยท JXG Shunt, Central Nervous System And Components
EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID
| Applicant | Cordis Corp., Miami FL, US |
| Decision | Substantially Equivalent, Jan 10, 1986 |
| Received | Dec 18, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K855058
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2016 | Integra LifeSciences Corp. Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box.
Used for Intraoperative drainage of CSF Terminated |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.