# K051984: Filterwire EZ (2.25 MM - 3.5 MM) Embolic Protection System, Models 20120-190, 20120-300

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Apr 10, 2006 after 262 days
- Product code: NFA (Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection)
- 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 K003992 (2001). 5 ancestors in all.
7 later devices descend from it; 1 cites it directly.
1 of 13 devices in its family (counting itself) has 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.
- K013913: Percusurge Guardwire Plus Temporary Occlusion and Aspiration System, Medtronic Percusurge, Inc. (2002) Summary page 1.

## Most influential descendants
- K061332: Filterwire EZ Embolic Protection System (2.25 MM-3.5 MM) (2006), 6 descendants of its own
- K063313: Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM) (2006), 4 descendants of its own
- K143570: Wirion (2015), 3 descendants of its own
- K180023: Wirion (2018), 2 descendants of its own
- K200198: Wirion (2020), 1 descendant of its own

## Indications for use
The FilterWire EZ Tm 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 coronary saphenous vein bypass grafts. The diameter of the vessel at the site of filter loop placement should be between 2.25 mm and 5.5 mm. · The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid, or peripheral vasculature. * The safety and effectiveness of the device as an embolic protection system has not been established in treating patients with acute myocardial infarction. * The safety and effectiveness of the device as an embolic protection system has not been established in treating native coronaries.

Source page: https://510kreport.com/device/K051984
Methodology: https://510kreport.com/methodology