# DRA: Catheter, Steerable

- Device class: 2; regulation: 21 CFR 870.1280; FDA's rule: 510(k) required
- FDA decisions: 42
- 510(k) review time 2021–2025: median 89 days (middle half 53–95)
- Recalls: 6 (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: 2
- 2018: 1
- 2019: 2
- 2020: 1
- 2021: 1
- 2022: 2
- 2023: 3
- 2025: 1
- 2026: 1

## Most-cited predicates
- K123591: Flexcath Advance Steerable Sheath (12 French) (2012), cited by 6
- K083793: Steerable Guide Catheter (2009), cited by 5
- K913940: Response (TM) Steerable Catheter (1993), cited by 4
- K091596: Evalve Steerable Guide Catheter, Model SGC01ST (2009), cited by 4
- K102176: Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model 3FC12, 3FC10 (2010), cited by 3
- K834352: Adult Vent Catheter (1984), cited by 3
- K100789: Modificaton to: Steerable Guide Catheter, Model SGC01ST (2010), cited by 3
- K093866: Evalve Steerable Guide Catheter (2010), cited by 3
- K120086: Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable Introducer 80CM (2012), cited by 2
- K081049: Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12 (2008), cited by 2

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