# LIT: Catheter, Angioplasty, Peripheral, Transluminal

- Device class: 2; regulation: 21 CFR 870.1250; FDA's rule: 510(k) required
- FDA decisions: 405
- 510(k) review time 2021–2025: median 92 days (middle half 42–207)
- Recalls: 21 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 9
- 2018: 6
- 2019: 4
- 2020: 9
- 2021: 4
- 2022: 8
- 2023: 6
- 2024: 6
- 2025: 3
- 2026: 4

## Most-cited predicates
- K103751: Mustang Balloon Dilatation Catheters (2011), cited by 10
- K971010: Peripheral Transluminal Angioplasty Catheters (1997), cited by 9
- K072947: Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters (2008), cited by 7
- K080982: Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters (2008), cited by 6
- K101062: Glider Pta Balloon Catheter (2010), cited by 6
- K971448: Cordis Opta LP Pta Balloon Catheter (1997), cited by 5
- K131199: Ultraverse RX Pta Balloon Dilatation Catheter (2013), cited by 5
- K970466: Radius Ptca Guidewire (1997), cited by 5
- K132430: Sterling Over-the-Wire (Otw) Pta Balloon Dilatation Catheter (2013), cited by 5
- K093286: Powercross .018 Otw Pta Dilation Catheter (2009), cited by 5

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