510(k) K932429 ยท JXG Shunt, Central Nervous System And Components
CORDIS GRAVITY COMPENSATING ACCESSORY
| Applicant | Cordis Corp., Miami Lakes FL, US |
| Decision | Substantially Equivalent, Jul 20, 1994 |
| Received | May 20, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932429
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2008 | Integra LifeSciences Corp. Gravity Compensating Accessory;
High Pressure Range, Sterile, Single Use, Rx only. CSF shunt accessory.
Manufacturer: Integra Neuro Sciences Implants, SA, Cedex, France;
distributed by: Integra Neu Terminated |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.