# PDU: Catheter For Crossing Total Occlusions

- Device class: 2; regulation: 21 CFR 870.1250; FDA's rule: 510(k) required
- FDA decisions: 58
- 510(k) review time 2021–2025: median 147 days (middle half 68–213)
- Recalls: 3 (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)
- 2016: 2
- 2017: 1
- 2019: 1
- 2020: 2
- 2021: 3
- 2022: 4
- 2023: 3
- 2024: 1
- 2025: 3
- 2026: 1

## Most-cited predicates
- K072776: The Crosser System (2007), cited by 5
- K040067: Clirpath Excimer Laser Catheter (2004), cited by 4
- K120533: Bigboss Catheters Mantatay Catheter Mantaray Guidewires (2012), cited by 4
- K031842: Safe-Cross Radio Frequency Total Occlusion Crossing System (2003), cited by 3
- K122380: Ocelot System (2012), cited by 3
- K051670: RF Tunneler Wire (2006), cited by 3
- K033535: Lumend Frontrunner Cto Catheter and Accessories (2004), cited by 3
- K052296: Clirpath Turbo Excimer Laser Catheters (2005), cited by 3
- K023114: Lumend Frontrunner Cto Catheter (2003), cited by 3
- K111338: Wildcat Catheter (2011), cited by 3

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