# K153086: RX ACCUNET Embolic Protection System

- Pathway: 510(k) (Special)
- Applicant: Abbott Vascular
- Decided: Nov 20, 2015 after 25 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: 4 generations back to K003992 (2001). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 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 4.
- K042218: Accunet Embolic Protection System, RX Accunet Embolic Protection System, Guidant Corp. (2004) Summary page 4.

## Most influential descendants
- K181128: Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) (2018), 1 descendant of its own
- K221339: Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection (2022), 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/K153086
Methodology: https://510kreport.com/methodology