# K111987: Fibernet Embolic Protection Device

- Pathway: 510(k) (Special)
- Applicant: Lumen Biomedical, Inc.
- Decided: Aug 17, 2011 after 35 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: 7 generations back to K010579 (2001). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082348: Fibernet Embolic Protection System, Lumen Biomedical, Inc. (2008) Summary page 1.

## 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/K111987
Methodology: https://510kreport.com/methodology