# K160257: PROTEK Duo 31 Fr. Veno-Venous Cannula Set

- Pathway: 510(k) (Special)
- Applicant: Cardiacassist, Inc.
- Decided: Mar 4, 2016 after 32 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: 3 generations back to K003288 (2001). 5 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 11 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.

## Most influential descendants
- K203067: Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F (2021), 2 descendants of its own
- K221353: Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS (2022), 1 descendant of its own
- K181150: ProtekDuo Mini Veno-Venous Cannula Set (2018), 1 descendant of its own
- K241248: Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) (2024), 0 descendants of its own
- K232480: ProtekDuo Veno-Venous Cannula Sets (2023), 0 descendants of its own

## Recalls of this device
- Oct 14, 2021 · Class III · Z-0311-2022: Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label showed expiration date of 2021/05/01 (incorrect expi

## Indications for use
The PROTEK Duo 31 Fr. Veno-Venous Cannula Set is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.

Source page: https://510kreport.com/device/K160257
Methodology: https://510kreport.com/methodology