# DQY: Catheter, Percutaneous

- Device class: 2; regulation: 21 CFR 870.1250; FDA's rule: 510(k) required
- FDA decisions: 896
- 510(k) review time 2021–2025: median 92 days (middle half 30–158)
- Recalls: 347 (10 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: 26
- 2018: 25
- 2019: 30
- 2020: 20
- 2021: 18
- 2022: 18
- 2023: 18
- 2024: 16
- 2025: 21
- 2026: 11

## Most-cited predicates
- K072313: Amplatzer Torqvue Delivery System (2007), cited by 11
- K111380: Neuron Max System (2011), cited by 10
- K905720: Palmaz Biliary Stent (1991), cited by 10
- K051772: Asahi Tornus Support Catheter (2005), cited by 10
- K033678: Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036, 518-037 and 518-038 (2004), cited by 9
- K053118: Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx (2005), cited by 9
- K070970: Neuron Support Catheter System, Model 5F/6F (2007), cited by 9
- K090849: Modification to: Nanocross 0.14 Otw Pta Dilatation Catheter, Models AB14W020210090, AB14W020210150 (2009), cited by 9
- K032869: Cook Coda Balloon Catheter (2003), cited by 9
- K072750: Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066 (2007), cited by 8

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