# K023691: Boston Scientific Filterwire EX Embolic

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Epi
- Decided: Jun 4, 2003 after 215 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: 1 generation back to K003992 (2001). 2 ancestors in all.
48 later devices descend from it; 4 cite it directly.
3 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003992: Percusurge Guardwire Temporary Occlusion and Aspiration System, Percu Surge, Inc. (2001) Summary page 1.
- K014223: Modification to Guardwire Plus Temporary Occlusion & Aspiration System, Medtronic Percusurge, Inc. (2002)

## Most influential descendants
- K032884: Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath (2004), 35 descendants of its own
- K042218: Accunet Embolic Protection System, RX Accunet Embolic Protection System (2004), 27 descendants of its own
- K052659: Spiderx Embolic Protection Device (2006), 18 descendants of its own
- K053195: Spiderx Embolic Protection Device (2006), 14 descendants of its own
- K062201: Spiderx Embolic Protection Device (2006), 13 descendants of its own

## Indications for use
The Filterwire EX Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/ debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.5 to 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.

Source page: https://510kreport.com/device/K023691
Methodology: https://510kreport.com/methodology