510(k) K914995 ยท JXG Shunt, Central Nervous System And Components
CORDIS STRAIGHT VENTRICULAR CATHETER
| Applicant | Cordis Corp., Miami Lakes FL, US |
| Decision | Substantially Equivalent, Mar 9, 1992 |
| Received | Nov 7, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914995
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2016 | Integra LifeSciences Corp. Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches ar Terminated |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.