# DWX: Stripper, Artery, Intraluminal

- Device class: 2; regulation: 21 CFR 870.4875; FDA's rule: 510(k) required
- FDA decisions: 14
- Recalls: 0 (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)
- 1984: 1
- 1989: 2
- 1990: 2
- 1991: 1
- 1992: 1
- 1994: 1
- 1995: 1
- 2001: 1
- 2003: 2
- 2012: 1

## Most-cited predicates
- K950813: Mollring Cutter (1995), cited by 1
- K003719: Vascular Architects Periscope Device (2001), cited by 1
- K890515: Peripheral Atherectomy System (1989), cited by 1
- K904944: Transluminal Endarterectomy Device (1990), cited by 1

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