# K062429: Modification to Embol-X Intra-Aortic Filter: X-Small, Small, Medium, Large, X-Large with Heparin Coated Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences Research Medical
- Decided: Sep 27, 2006 after 37 days
- Product code: DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line)
- Device class: 2
- Regulation: 21 CFR 870.4260
- Recalls of this device: none
- 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.
0 of 3 devices in its family (counting itself) have 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 Intra-aortic Filters: 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

## Indications for use
The EmboI-X Intra-aortic filter is indicated for use with the Embol-X Access Device/Aortic Cannula in first time, non emergent cardiac surgery procedures requiring aortic crossclamp, to capture and remove particulate emboli from the ascending aorta and heart in patients aged 18 years and older.

Source page: https://510kreport.com/device/K062429
Methodology: https://510kreport.com/methodology