# K140999: Tandemheart Veno-Venous Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Cardiacassist, Inc.
- Decided: Aug 6, 2014 after 110 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003288 (2001). 4 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081820: Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR, Avalon Laboratories, LLC (2008) Summary page 4.
- K133236: Tandemheart Femoral Venous Cannula Set, Cardiacassist, Inc. (2014) Summary page 4.

## Most influential descendants
- K160257: PROTEK Duo 31 Fr. Veno-Venous Cannula Set (2016), 5 descendants of its own
- 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

## Indications for use
The TandemHeart 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/K140999
Methodology: https://510kreport.com/methodology