# K061332: Filterwire EZ Embolic Protection System (2.25 MM-3.5 MM)

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Aug 11, 2006 after 91 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: 4 generations back to K003992 (2001). 6 ancestors in all.
6 later devices descend from it; 2 cite 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)
- K051984: Filterwire EZ (2.25 MM - 3.5 MM) Embolic Protection System, Models 20120-190, 20120-300, Boston Scientific Corp (2006) Summary page 2.

## Most influential descendants
- 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
- K210282: WIRION Embolic Protection System (2021), 0 descendants of its own

## Indications for use
The indications for use for the FilterWire EZ Embolic Protection System are as follows: The FilterWire EZ 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 artery 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 cerebral, carotid and peripheral vasculature or in treating native coronaries, including acute myocardial infarction.

Source page: https://510kreport.com/device/K061332
Methodology: https://510kreport.com/methodology