# K162214: Protek Solo 24 Fr Venous Cannula Set

- Pathway: 510(k) (Traditional)
- Applicant: Cardiacassist, Inc.
- Decided: Nov 30, 2016 after 114 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.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133236: Tandemheart Femoral Venous Cannula Set, Cardiacassist, Inc. (2014) Summary page 4.
- K140999: Tandemheart Veno-Venous Cannula, Cardiacassist, Inc. (2014) Summary page 4.

## Recalls of this device
- Nov 19, 2019 · Class II · Z-1106-2020: The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.

## Indications for use
The Protek Solo 24 Fr Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The 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/K162214
Methodology: https://510kreport.com/methodology