# K052166: Modification to:  RX Accunet Embolic Protection System

- Pathway: 510(k) (Special)
- Applicant: Guidant Corporation
- Decided: Aug 18, 2005 after 9 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: 3 generations back to K003992 (2001). 5 ancestors in all.
13 later devices descend from it; 3 cite it directly.
2 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042218: Accunet Embolic Protection System, RX Accunet Embolic Protection System, Guidant Corp. (2004) Summary page 5.
- K042908: RX Accunet 2 Embolic Protection System, Guidant Corp. (2004) Summary page 5.

## Most influential descendants
- 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
- K153086: RX ACCUNET Embolic Protection System (2015), 2 descendants of its own
- K143072: ENROUTE Transcarotid Neuroprotection System (2015), 2 descendants of its own
- K181128: Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) (2018), 1 descendant of its own

## Indications for use
The RX ACCUNET™ Embolic Protection System Is indicated for use as a guide wire 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/K052166
Methodology: https://510kreport.com/methodology