# K022071: Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra Large,Models CF26000.CF29000,CF32000,CF35000,CF4000

- Pathway: 510(k) (Traditional)
- Applicant: Embol-X, Inc.
- Decided: Feb 14, 2003 after 233 days
- Product code: DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line)
- Device class: 2
- Regulation: 21 CFR 870.4260
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K820044 (1982). 2 ancestors in all.
3 later devices descend from it; 2 cite 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)
- 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
- K031946: Embol-X Intra-Aortic Filter: Extra-Small, Small, Medium, Large, Extra-Large (2003), 2 descendants of its own
- 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 Aortic Filter is indicated for use with the EMBOL-X Aortic Cannula in cardiac surgery procedures to capture and remove particulate emboli from the ascending aorta and heart during and following cross clamp removal in patients aged 60 years and older undergoing first time non-emergent CABG or isolated aortic or mitral valve repair/replacement.

Source page: https://510kreport.com/device/K022071
Methodology: https://510kreport.com/methodology