# K063204: Spiderfx Embolic Protection Device

- Pathway: 510(k) (Special)
- Applicant: Ev3, Inc.
- Decided: Nov 14, 2006 after 22 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: 4 generations back to K003992 (2001). 6 ancestors in all.
8 later devices descend from it; 3 cite it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052659: Spiderx Embolic Protection Device, Ev3, Inc. (2006) Summary page 1.

## Most influential descendants
- K111010: Spiderfx Embolic Protection Device (2011), 4 descendants of its own
- K180023: Wirion (2018), 2 descendants of its own
- K200198: Wirion (2020), 1 descendant of its own
- K103500: Gore Embolic Filter (2011), 1 descendant of its own
- K222694: EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) (2023), 0 descendants of its own

## Indications for use
The SpiderFXTM 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/K063204
Methodology: https://510kreport.com/methodology