# K102420: Embol-X Access Device/ Aortic Cannula, Embol-X Slim Accessdevice/ Aortic Cannula, Embol-X Glide Access Device/ Aortic CA

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: Oct 26, 2010 after 62 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) EMBOL-X Aortic Cannula: named in the summary without a submission number

## Most influential descendants
- K141465: Cardiogard Emboli Protection Cannula (2015), 1 descendant of its own
- K182302: CardioGard Emboli Protection Cannula (2019), 0 descendants of its own

## Recalls of this device
- Sep 16, 2013 · Class I · Z-0091-2014: Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip.

## Indications for use
The EMBOL-X Access Device /Aortic Cannula is indicated for the perfusion of the ascending aorta during short-term (S56 hours) cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.

Source page: https://510kreport.com/device/K102420
Methodology: https://510kreport.com/methodology