# K031946: Embol-X Intra-Aortic Filter: Extra-Small, Small, Medium, Large, Extra-Large

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Nov 3, 2003 after 132 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
Longest line of descent: 2 generations back to K820044 (1982). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022071: Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra Large,Models CF26000.CF29000,CF32000,CF35000,CF4000, Embol-X, Inc. (2003) Summary page 2.
- K003992: Percusurge Guardwire Temporary Occlusion and Aspiration System, Percu Surge, Inc. (2001) Summary page 2.
- K820044: Arterial Blood Filter, #AF-1025, Bentley Laboratories, Inc. (1982) Summary page 2.

## 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 EMBOL-X Intra-aortic Filter is indicated for use with the EMBOL-X Aortic Cannula in first time, non-emergent cardiac surgery procedures to capture and remove particulate emboli from the ascending aorta and heart during and following cross clamp removal in patients aged 18 years and older.

Source page: https://510kreport.com/device/K031946
Methodology: https://510kreport.com/methodology