# DXE: Catheter, Embolectomy

- Device class: 2; regulation: 21 CFR 870.5150; FDA's rule: 510(k) required
- FDA decisions: 74
- 510(k) review time 2021–2025: median 173 days (middle half 115–210)
- Recalls: 42 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2002: 2
- 2003: 1
- 2008: 1
- 2010: 2
- 2015: 1
- 2017: 2
- 2020: 1
- 2021: 1
- 2022: 1
- 2024: 5

## Most-cited predicates
- K972511: Amplatz Goose Neck Snare Kit/ Catheter (1998), cited by 7
- K892410: Fogarty (R) Thru-Lumen Embolectomy Catheter (1989), cited by 6
- K081573: Medtronic Export AP Catheter (2008), cited by 4
- K901627: Arterial Embolectomy Catheter (1990), cited by 2
- K152335: Export Advance Aspiration Catheter (2015), cited by 2
- K970762: Dual Lumen Embolectomy Catheter (1997), cited by 2
- K973465: Latis Graft Cleaning Catheter (1998), cited by 2
- K901625: Fogarty Arterial Embolectomy II Catheter (1990), cited by 2
- K920871: J-Lloyd Arterial Embolectomy Catheter (1993), cited by 1
- K902327: Embolectomy Catheter (1991), cited by 1

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