# K063313: Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM)

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Dec 5, 2006 after 33 days
- Product code: NTE (Temporary Carotid Catheter For Embolic Capture)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K003992 (2001). 8 ancestors in all.
4 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.
- K061332: Filterwire EZ Embolic Protection System (2.25 MM-3.5 MM), Boston Scientific Corp (2006) Summary page 1.
- K042218: Accunet Embolic Protection System, RX Accunet Embolic Protection System, Guidant Corp. (2004) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- May 20, 2008 · Not classified · Z-0105-2009: Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic Protection System. Boston Scientific has determined that the Directions for Use (DFU), which accom
- May 20, 2008 · Not classified · Z-0108-2009: Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic Protection System. Boston Scientific has determined that the Directions for Use (DFU), which accom
- May 20, 2008 · Not classified · Z-0110-2009: Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic Protection System. Boston Scientific has determined that the Directions for Use (DFU), which accom
- May 20, 2008 · Not classified · Z-0106-2009: Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic Protection System. Boston Scientific has determined that the Directions for Use (DFU), which accom
- May 20, 2008 · Not classified · Z-0107-2009: Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic Protection System. Boston Scientific has determined that the Directions for Use (DFU), which accom
- May 20, 2008 · Not classified · Z-0109-2009: Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic Protection System. Boston Scientific has determined that the Directions for Use (DFU), which accom

## Indications for use
The FilterWire EZTM 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 and carotid arteries. The diameter of the vessel at the site of filter loop placement should be between 2.25 mm and 5.5 mm for coronary saphenous vein bypass graft procedures and between 3.5 mm and 5.5 mm for carotid procedures. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral vasculature, peripheral vessels other than carotid arteries, or in treating native coronaries, including acute myocardial infarction.

Source page: https://510kreport.com/device/K063313
Methodology: https://510kreport.com/methodology