# MWS: Stabilizer, Heart

- Device class: 1; regulation: 21 CFR 870.4500; FDA's rule: 510(k) exempt
- FDA decisions: 4
- Recalls: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1999: 2
- 2000: 1
- 2004: 1

## Most-cited predicates
- K992833: Vacuum Assist Stabilizer (1999), cited by 2
- K041338: Medtronic Octopus TE Stabilizer & Accessories (2004), cited by 2
- K982419: Heart-Lift Balloon Positioner (1999), cited by 1

Source page: https://510kreport.com/product-code/MWS
Data by year (CSV): https://510kreport.com/product-code/MWS.csv