# K020728: Miethke Shunt System

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: Apr 5, 2002 after 30 days
- Product code: HCA (Catheter, Ventricular)
- Device class: 2
- Regulation: 21 CFR 882.4100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K944222 (1995). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980778: Hakim Micro Programmable Valve System, Johnson & Johnson Professionals, Inc. (1998) Summary page 1.
- K961859: Novus Standard and Pediatric Valves, Integra Neurocare, LLC (1996) Summary page 1.
- K902783: PS Medical Delta CSF-Flow Control Valve, Pudenz-Schulte Medical Research Corp. (1990) Summary page 1.
- K932429: Cordis Gravity Compensating Accessory, Cordis Corp. (1994) Summary page 1.
- K861377: Standard/Pediatric Cordis Hydrocephalus Valves, Cordis Corp. (1986) Summary page 1.

## Cited in the summary but kept off the family tree
- K811410: Medi-Trace, Graphic Controls Corp. (1981). Our OCR of the scanned summary read K811410, FDA’s number for Medi-Trace (Graphic Controls Corp.), which shares no word with the summary’s name for the device, “P/S Medtronic Bulton”, apart from generic ones like “system”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K242003: XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (2024), 0 descendants of its own
- K200950: Ventricular Catheter (2020), 0 descendants of its own

## Recalls of this device
- Jun 4, 2012 · Class II · Z-0805-2013: The deflector may not move freely on the ventricular catheter. The deflector comes pre-positioned at the 5 cm mark on the catheter. In some cases the surgeon will want to adjust the deflector to a dif

## 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/K020728
Methodology: https://510kreport.com/methodology