# DXF: Catheter, Septostomy

- Device class: 2; regulation: 21 CFR 870.5175; FDA's rule: 510(k) required
- FDA decisions: 21
- 510(k) review time 2021–2025: median 30 days (middle half 28–88)
- Recalls: 4 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2003: 1
- 2008: 1
- 2015: 1
- 2019: 1
- 2021: 1
- 2022: 1
- 2023: 1
- 2024: 4
- 2025: 2
- 2026: 3

## Most-cited predicates
- K073326: NRG Transseptal Needle (2008), cited by 5
- K150709: ProTrack RF Anchor Wire (2015), cited by 3
- K242076: VersaCross™ RF Wire (2024), cited by 2
- K241414: CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W,  CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) (2024), cited by 2
- K011557: Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters (2001), cited by 2
- K240900: HOTWIRE™ RF Guidewire (2024), cited by 1
- K801031: Blade Septostomy Catheter (1980), cited by 1
- K252419: Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX) (2025), cited by 1
- K232852: Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable (2023), cited by 1
- K001804: Numed Z-5 Atrioseptostomy Catheter (2000), cited by 1

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