# K042908: RX Accunet 2 Embolic Protection System

- Pathway: 510(k) (Special)
- Applicant: Guidant Corp.
- Decided: Nov 12, 2004 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
No predicates in its family tree.
20 later devices descend from it; 2 cite it directly.
2 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K024418: RX ACCUNET Embolic Protection System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Most influential descendants
- K052454: The Emboshield Embolic Protection System (2005), 14 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
- K083300: Gore Flow Reversal System (2009), 5 descendants of its own
- K081523: Emboshield NAV6 Embolic Protection System (2008), 4 descendants of its own

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

Source page: https://510kreport.com/device/K042908
Methodology: https://510kreport.com/methodology