# K052165: RX Accunet Embolic Protection System

- Pathway: 510(k) (Special)
- Applicant: Guidant Corporation
- Decided: Aug 16, 2005 after 7 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). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 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 4.

## 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 5.

## Most influential descendants
- K081549: RX Accunet LP Embolic Protection System (2008), 0 descendants 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/K052165
Methodology: https://510kreport.com/methodology