# K133236: Tandemheart Femoral Venous Cannula Set

- Pathway: 510(k) (Traditional)
- Applicant: Cardiacassist, Inc.
- Decided: Jan 29, 2014 after 100 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: 1 generation back to K924642 (1993). 1 ancestor in all.
8 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924642: Medtronic Bio-Medicus Femoral Cannula/Introducer, Medtronic Bio-Medicus, Inc. (1993) Summary page 1.

## Most influential descendants
- K140999: Tandemheart Veno-Venous Cannula (2014), 7 descendants of its own
- 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

## Indications for use
The TandemHeart Venous Cannula Set is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The cannula obturator and dilator are intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support.

Source page: https://510kreport.com/device/K133236
Methodology: https://510kreport.com/methodology