# DQT: Occluder, Catheter Tip

- Device class: 2; regulation: 21 CFR 870.1370; FDA's rule: 510(k) required
- FDA decisions: 12
- Recalls: 3 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1984: 1
- 1985: 1
- 1986: 1
- 1987: 3
- 1988: 2
- 1991: 2
- 1995: 1
- 1999: 1

## Most-cited predicates
- K983927: GT1 Floppy, GT1 HI-Per Flex, GT1 Light Support (1999), cited by 4

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