# DQR: Cannula, Catheter

- Device class: 2; regulation: 21 CFR 870.1300; FDA's rule: 510(k) required
- FDA decisions: 25
- Recalls: 18 (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)
- 1987: 3
- 1988: 5
- 1989: 5
- 1990: 1
- 1991: 1
- 1996: 1
- 2003: 1
- 2005: 1
- 2008: 1
- 2013: 1

## Most-cited predicates
- K902674: Datascope Arterial Cannula W/Access Port (1991), cited by 2
- K030398: Cardiacassist Transseptal Cannula Set, Model 5132-6221 (2003), cited by 2
- K884375: Translumbar Aortography Needle Catheter (1989), cited by 1
- K073559: 18 FR. Rmi Arterial Perfusion Cannula II, 20 FR. Rmi Arterial Perfusion Cannula II (2008), cited by 1
- K870825: New Model Styles for Aortic Arch Cannula (1987), cited by 1

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