# MOF: Guide, Wire, Catheter, Neurovasculature

- Device class: 2; regulation: 21 CFR 870.1330; FDA's rule: 510(k) required
- FDA decisions: 45
- 510(k) review time 2021–2025: median 198 days (middle half 99–231)
- 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)
- 2016: 4
- 2017: 1
- 2018: 2
- 2019: 4
- 2020: 4
- 2022: 1
- 2023: 4
- 2024: 2
- 2025: 5
- 2026: 11

## Most-cited predicates
- K110584: Asahi Chikai Neurovascular Guide Wire (2011), cited by 6
- K133725: Traxcess 14 Guidewire (2014), cited by 4
- K141751: Asahi Neurovascular Guide Wire Asahi Chikai 008, Asahi Neurovascular Guide Wire Asahi Chikai Black, Asahi Neurovascular (2015), cited by 4
- K231954: Aristotle 18 Guidewire; Aristotle 24 Guidewire (2023), cited by 3
- K183608: Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile (2019), cited by 3
- K222437: Aristotle Colossus Guidewire (2023), cited by 3
- K161803: Traxcess .007 Mini Guidewire (2016), cited by 2
- K253168: 0.014” Willow Guidewire (2025), cited by 2
- K153053: Traxcess Pro 14 Guidewire (2015), cited by 2
- K112979: Asahi Chikai 10 Neurovascular Guide Wire (2011), cited by 2

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