# K120543: Tandemheart Femoral Arterial Cannula Set

- Pathway: 510(k) (Traditional)
- Applicant: Cardiacassist, Inc.
- Decided: May 30, 2012 after 97 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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
- K133293: 15 FR. Tandemheart Arterial Cannula (2014), 0 descendants of its own

## Indications for use
The Femoral Arterial Cannula and Introducer is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment for a duration of six hours or less. The cannula introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.

Source page: https://510kreport.com/device/K120543
Methodology: https://510kreport.com/methodology