# K063785: Spiderfx Embolic Protection Device

- Pathway: 510(k) (Special)
- Applicant: Ev3, Inc.
- Decided: Jan 19, 2007 after 29 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: 5 generations back to K003992 (2001). 7 ancestors in all.
12 later devices descend from it; 2 cite it directly.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062201: Spiderx Embolic Protection Device, Ev3, Inc. (2006) Summary page 1.

## Most influential descendants
- K090364: Extra Pta Balloon Catheter with Embolic Protection Feature (2010), 10 descendants of its own
- K111750: Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon Catheter with Embolic Capture Feature (2011), 5 descendants of its own
- K111010: Spiderfx Embolic Protection Device (2011), 4 descendants of its own
- K120805: Proteus Pta Balloon Catheter with Embolic Capture Feature (2012), 3 descendants of its own
- K180023: Wirion (2018), 2 descendants of its own

## Indications for use
The SpiderFXTM Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral or peripheral vasculature.

Source page: https://510kreport.com/device/K063785
Methodology: https://510kreport.com/methodology