# K853361: H-H Ventricular Catheters & Reservoirs

- Pathway: 510(k) (Traditional)
- Applicant: Holter-Hausner Intl.
- Decided: Aug 28, 1985 after 16 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Mar 24, 2005 · Not classified · Z-0365-06: stylet in package is shorter than that claimed on the label
- Mar 24, 2005 · Not classified · Z-0366-06: stylet in package is shorter than that claimed on the label
- Mar 24, 2005 · Not classified · Z-0367-06: stylet in package is shorter than that claimed on the label

Source page: https://510kreport.com/device/K853361
Methodology: https://510kreport.com/methodology