# K021644: Perf (Ommaya Style) Reservoirs

- Pathway: 510(k) (Traditional)
- Applicant: Phoenix Biomedical Corp.
- Decided: Aug 6, 2002 after 78 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: none
- 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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Perf (Ommaya Style) Reservoir is intended as a means of gaining access to the cerebral ventricles by hypodermic puncture. It may be used for obtaining CSF samples, for monitoring intraventricular pressure, and for ventricular drainage. The Perf (Ommaya Style) Reservoir may be used to access the ventricles or cystic tumors for the injection of chemotherapeutic agents and/or radioisotopes.

Source page: https://510kreport.com/device/K021644
Methodology: https://510kreport.com/methodology