# K855058: Evds, Evmds, LDS & Ivmcs Central Nervous Sys Fluid

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Jan 10, 1986 after 23 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K964923: Codman Lumbar Drainage Catheter Kit (1997), 2 descendants of its own
- K242974: External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters (2025), 0 descendants of its own
- K021196: Neuron Therapeutics, Inc., 14-Gauge Lumbar Puncture Set, Model PN1000735 (2002), 0 descendants of its own

## Recalls of this device
- Aug 23, 2016 · Class II · Z-2908-2016: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

Source page: https://510kreport.com/device/K855058
Methodology: https://510kreport.com/methodology