# K082348: Fibernet Embolic Protection System

- Pathway: 510(k) (Traditional)
- Applicant: Lumen Biomedical, Inc.
- Decided: Nov 18, 2008 after 95 days
- Product code: NTE (Temporary Carotid Catheter For Embolic Capture)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K010579 (2001). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032884: Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath, Boston Scientific Epi (2004) Summary page 1.
- K052659: Spiderx Embolic Protection Device, Ev3, Inc. (2006) Summary page 1.
- K072990: Guardwire Temporary Occlusion and Aspiration System- Carotid, Medtronic, Inc. (2007) Summary page 1.
- K071529: Xtract Catheter System, Lumen Biomedical, Inc. (2007) Summary page 1.

## Most influential descendants
- K111987: Fibernet Embolic Protection Device (2011), 0 descendants of its own

## Recalls of this device
- Mar 3, 2014 · Class II · Z-1304-2014: Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during
- Mar 3, 2014 · Class II · Z-1303-2014: Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during

## Indications for use
The FiberNet ® Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 to 7.0 mm.

Source page: https://510kreport.com/device/K082348
Methodology: https://510kreport.com/methodology