# K133293: 15 FR. Tandemheart Arterial Cannula

- Pathway: 510(k) (Special)
- Applicant: Cardiacassist, Inc.
- Decided: Feb 12, 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 K924642 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120543: Tandemheart Femoral Arterial Cannula Set, Cardiacassist, Inc. (2012) Summary page 1.
- K924642: Medtronic Bio-Medicus Femoral Cannula/Introducer, Medtronic Bio-Medicus, Inc. (1993) Summary page 1.

## Indications for use
The 15 French TandemHeart Arterial Cannula Set (15 Fr. THAC) is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. 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/K133293
Methodology: https://510kreport.com/methodology