# K080034: Three Stage Venous Return Cannula, Model 816460

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Jun 17, 2008 after 162 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K810415 (1981). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810415: Sarns Two-State Wire Reinforced Catheter, 3M Health Care, Sarns (1981) Summary page 2.

## Recalls of this device
- May 23, 2014 · Class II · Z-2104-2014: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications

## Indications for use
These cannulae are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Source page: https://510kreport.com/device/K080034
Methodology: https://510kreport.com/methodology