# K052454: The Emboshield Embolic Protection System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Vascular Devices
- Decided: Sep 14, 2005 after 8 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: 1 generation back to K042908 (2004). 1 ancestor in all.
14 later devices descend from it; 2 cite it directly.
2 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042908: RX Accunet 2 Embolic Protection System, Guidant Corp. (2004) Summary page 4.

## Most influential descendants
- K072990: Guardwire Temporary Occlusion and Aspiration System- Carotid (2007), 8 descendants of its own
- K083300: Gore Flow Reversal System (2009), 5 descendants of its own
- K081523: Emboshield NAV6 Embolic Protection System (2008), 4 descendants of its own
- K110909: Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wire-Workhorse-190CM / 315CM, Barewire Filter Del.. (2011), 3 descendants of its own
- K143072: ENROUTE Transcarotid Neuroprotection System (2015), 2 descendants of its own

## Indications for use
The Emboshield Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove emboalic 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 2.8 mm and 6.2 mm.

Source page: https://510kreport.com/device/K052454
Methodology: https://510kreport.com/methodology