# K081549: RX Accunet LP Embolic Protection System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Aug 19, 2008 after 77 days
- Product code: NTE (Temporary Carotid Catheter For Embolic Capture)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003992 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052166: Modification to:  RX Accunet Embolic Protection System, Guidant Corporation (2005) Summary page 1.
- K052165: RX Accunet Embolic Protection System, Guidant Corporation (2005) Summary page 1.

## Recalls of this device
- Nov 30, 2011 · Class II · Z-0757-2013: The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX Accunet Embolic Protection System may exhibit difficult removal of the peel away sheath due to higher 

## Indications for use
The RX Accunet® LP 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 3.25mm to 7.0mm.

Source page: https://510kreport.com/device/K081549
Methodology: https://510kreport.com/methodology