# K042218: Accunet Embolic Protection System, RX Accunet Embolic Protection System

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Aug 31, 2004 after 26 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: 2 generations back to K003992 (2001). 3 ancestors in all.
27 later devices descend from it; 7 cite it directly.
3 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023691: Boston Scientific Filterwire EX Embolic, Boston Scientific Epi (2003) Summary page 4.

## Most influential descendants
- K052659: Spiderx Embolic Protection Device (2006), 18 descendants of its own
- K052166: Modification to:  RX Accunet Embolic Protection System (2005), 13 descendants of its own
- 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

## Indications for use
The ACCUNET ™ Embolic Protection System and the RX ACCUNET™ Embolic Protection System are 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 3.25 mm and 7.0 mm.

Source page: https://510kreport.com/device/K042218
Methodology: https://510kreport.com/methodology