# K110909: Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wire-Workhorse-190CM / 315CM, Barewire Filter Del..

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Apr 29, 2011 after 29 days
- Product code: NTE (Temporary Carotid Catheter For Embolic Capture)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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 K042908 (2004). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081523: Emboshield NAV6 Embolic Protection System, Abbott Vascular-Vascular Solutions (2008) Summary page 1.
- K090665: Emboshield NAV6 Embolic Protection System-Small/Large, Model 22437-19/22438-19, Abbott Vascular-Vascular Solutions (2009) Summary page 1.

## Most influential descendants
- K121015: Emboshield NAV6 Embolic Protection System (2012), 2 descendants of its own
- K141678: Emboshield NAV6 Embolic Protection System (2014), 1 descendant of its own
- K191173: Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires (2019), 0 descendants of its own

## Indications for use
The Emboshield NAV 6 Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of the Filtration Element placement should be between 2.5 and 7.0 mm.

Source page: https://510kreport.com/device/K110909
Methodology: https://510kreport.com/methodology