# K031303: Aesculap-Miethke Shunt System Gravity Assisted Valve (Gav)

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: Jun 4, 2003 after 41 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.
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. The FDA summary names its predicate without a number.
- (no number) Miethke Shunt System with Paedi-Gav-Valve: named in the summary without a submission number
- (no number) Dualswitch Valve: named in the summary without a submission number

## Recalls of this device
- Apr 21, 2014 · Class II · Z-1676-2014: AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.

## Indications for use
The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

Source page: https://510kreport.com/device/K031303
Methodology: https://510kreport.com/methodology