# K111010: Spiderfx Embolic Protection Device

- Pathway: 510(k) (Traditional)
- Applicant: Ev3, Inc.
- Decided: Oct 27, 2011 after 199 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: 7 generations back to K003992 (2001). 14 ancestors in all.
4 later devices descend from it; 2 cite it directly.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063204: Spiderfx Embolic Protection Device, Ev3, Inc. (2006) Summary page 1.
- K052659: Spiderx Embolic Protection Device, Ev3, Inc. (2006) Summary page 1.
- K090364: Extra Pta Balloon Catheter with Embolic Protection Feature, Angioslide, Ltd. (2010) Summary page 1.

## Most influential descendants
- 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
- K181529: Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection (2018), 0 descendants of its own

## Indications for use
The SpiderFX®0 Embolic Protection Device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material in conjunction with the TurboHawk, either during standalone procedures or together with PTA and/or stenting, in the treatment of severely calcified lesions in arteries of the lower extremities.

Source page: https://510kreport.com/device/K111010
Methodology: https://510kreport.com/methodology