# K182302: CardioGard Emboli Protection Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Cardiogard Medical, Ltd.
- Decided: May 17, 2019 after 266 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: 4 generations back to K820044 (1982). 8 ancestors in all.
No later device cites it as a predicate yet.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141465: Cardiogard Emboli Protection Cannula, Cardiogard Medical, Ltd. (2015) Summary page 4.

## Indications for use
The CardioGard Emboli Protection Cannula combines the function of a standard arterial cannula with an added suction mechanism to capture debris that may result from cardiac surgery. The CardioGard Emboli Protection Cannula is intended for perfusion of the ascending aorta during short term (<6 hours) cardiopulmonary bypass (CPB) procedures. The CardioGard suction lumen is intended for the removal of particulate emboli during surgical procedures that require CPB.

Source page: https://510kreport.com/device/K182302
Methodology: https://510kreport.com/methodology