# K232480: ProtekDuo Veno-Venous Cannula Sets

- Pathway: 510(k) (Traditional)
- Applicant: Cardiacassist, Inc.
- Decided: Oct 6, 2023 after 51 days
- Product code: PZS (Dual Lumen Ecmo Cannula)
- Device class: 2
- Regulation: 21 CFR 870.4100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K003288 (2001). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140999: Tandemheart Veno-Venous Cannula, Cardiacassist, Inc. (2014) Summary page 4.
- K160257: PROTEK Duo 31 Fr. Veno-Venous Cannula Set, Cardiacassist, Inc. (2016) Summary page 4.
- K181150: ProtekDuo Mini Veno-Venous Cannula Set, Cardiacassist, Inc. (2018) Summary page 4.
- K081820: Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR, Avalon Laboratories, LLC (2008) Summary page 4.
- K180151: MC3 Jugular Dual Lumen Catheter, Mc3 Incorporated (2018) Summary page 4.
- (no number) 81 FR 7451, Feb. 12, 2016: named in the summary without a submission number

## Indications for use
The ProtekDuo Veno-Venous Cannula is a single use dual lumen cannula, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in adult patients with acute respiratory failure requiring Veno-Venous Extracorporeal Membrane Oxygenation, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

Source page: https://510kreport.com/device/K232480
Methodology: https://510kreport.com/methodology