# K103003: Aesculap- Meithke Progav Programmable Shunt System

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: Nov 9, 2010 after 28 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K944222 (1995). 17 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062009: Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451T, Aesculap, Inc. (2007) Summary page 1.

## Most influential descendants
- K141687: Aesculap - Meithke Progav 2.0 Adjustable Shunt System (2015), 2 descendants of its own
- K120559: Aesculap-Meithke Prosa Adjustable Shunt System (2012), 2 descendants of its own
- K161853: proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System (2017), 1 descendant of its own
- K192266: M. Blue Adjustable Shunt System (2019), 0 descendants of its own

## Recalls of this device
- Nov 16, 2010 · Not classified · Z-0839-2011: Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism.
- Nov 16, 2010 · Not classified · Z-0840-2011: Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism.
- Nov 16, 2010 · Not classified · Z-0842-2011: Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism.
- Nov 16, 2010 · Not classified · Z-0838-2011: Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism.
- Nov 16, 2010 · Not classified · Z-0841-2011: Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism.

## Indications for use
The Miethke proGAV Programmable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. Adjustments of the proGAV shunt can be verified by using the verification instrument but must be confirmed by radiograph (X-ray).

Source page: https://510kreport.com/device/K103003
Methodology: https://510kreport.com/methodology