# K141465: Cardiogard Emboli Protection Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Cardiogard Medical, Ltd.
- Decided: Jan 9, 2015 after 220 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: 3 generations back to K820044 (1982). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102420: Embol-X Access Device/ Aortic Cannula, Embol-X Slim Accessdevice/ Aortic Cannula, Embol-X Glide Access Device/ Aortic CA, Edwards Lifesciences, LLC (2010) Summary page 4.
- K020693: Aortic Cannula, Metal J-Tip (24FR) Model #CF00100; Aortic Cannula, Plastic J-Tip (24FR) Model #CF00101, Embol-X, Inc. (2002) Summary page 4.
- K062429: Modification to Embol-X Intra-Aortic Filter: X-Small, Small, Medium, Large, X-Large with Heparin Coated Mesh, Edwards Lifesciences Research Medical (2006) Summary page 4.
- K031946: Embol-X Intra-Aortic Filter: Extra-Small, Small, Medium, Large, Extra-Large, Edwards Lifesciences, LLC (2003) Summary page 4.
- K022071: Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra Large,Models CF26000.CF29000,CF32000,CF35000,CF4000, Embol-X, Inc. (2003) Summary page 4.

## Most influential descendants
- K182302: CardioGard Emboli Protection Cannula (2019), 0 descendants of its own

## 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/K141465
Methodology: https://510kreport.com/methodology