# DYB: Introducer, Catheter

- Device class: 2; regulation: 21 CFR 870.1340; FDA's rule: 510(k) required
- FDA decisions: 707
- 510(k) review time 2021–2025: median 59 days (middle half 30–128)
- Recalls: 278 (48 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 24
- 2018: 19
- 2019: 18
- 2020: 9
- 2021: 12
- 2022: 13
- 2023: 15
- 2024: 18
- 2025: 16
- 2026: 17

## Most-cited predicates
- K081645: Agilis NXT Steerable Introducer, Model G408324 (2008), cited by 16
- K061363: Agilis NXT Steerable Introducer (2006), cited by 15
- K964518: Fast-Cath Transseptal Catheter Introducer (1997), cited by 9
- K003731: Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve (2001), cited by 9
- K082644: Glidesheath (2008), cited by 9
- K924607: Arrow Fischell Kink Resist Percut Sheath Intro Set (1993), cited by 8
- K091329: Pinnacle Destination Peripheral Guiding Sheath (2009), cited by 8
- K160254: GORE DrySeal Flex Introducer Sheath (2016), cited by 6
- K970229: Arrow Transseptal Super Arrow-Flex Percutaneous Set (1998), cited by 6
- K000313: Tearaway Introducer Sheath (2000), cited by 6

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