# K121015: Emboshield NAV6 Embolic Protection System

- Pathway: 510(k) (Special)
- Applicant: Abbott Vascular
- Decided: May 4, 2012 after 30 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: 4 generations back to K042908 (2004). 5 ancestors in all.
2 later devices descend from it; 1 cites 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). Our reading of the summary gave K051523, FDA’s number for Regius Console CS-2000 and Regius Console CS-3000, Medical… (Konica Minolta Medical & Graphic, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Emboshield NAV 6 Embolic Protection System”.
- K090665: Emboshield NAV6 Embolic Protection System-Small/Large, Model 22437-19/22438-19, Abbott Vascular-Vascular Solutions (2009) Summary page 1.
- K110909: Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wire-Workhorse-190CM / 315CM, Barewire Filter Del.., Abbott Laboratories (2011) Summary page 3.

## Most influential descendants
- 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/K121015
Methodology: https://510kreport.com/methodology