# K052659: Spiderx Embolic Protection Device

- Pathway: 510(k) (Traditional)
- Applicant: Ev3, Inc.
- Decided: Feb 17, 2006 after 143 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: 3 generations back to K003992 (2001). 5 ancestors in all.
18 later devices descend from it; 4 cite it directly.
3 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042218: Accunet Embolic Protection System, RX Accunet Embolic Protection System, Guidant Corp. (2004) Summary page 1.
- K032884: Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath, Boston Scientific Epi (2004) Summary page 1.

## Most influential descendants
- K072990: Guardwire Temporary Occlusion and Aspiration System- Carotid (2007), 8 descendants of its own
- K063204: Spiderfx Embolic Protection Device (2006), 8 descendants of its own
- K083300: Gore Flow Reversal System (2009), 5 descendants of its own
- K111010: Spiderfx Embolic Protection Device (2011), 4 descendants of its own
- K180023: Wirion (2018), 2 descendants of its own

## Indications for use
The SpideRX Embolic Protection Device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be between 3.0mm and 7.0mm.

Source page: https://510kreport.com/device/K052659
Methodology: https://510kreport.com/methodology