# K181128: Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)

- Pathway: 510(k) (Traditional)
- Applicant: Contego Medical, LLC
- Decided: Sep 6, 2018 after 129 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- 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: 7 generations back to K001134 (2000). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141150: Pta Balloon Dilatation Catheter, Boston Scientific Corp (2014) Summary page 5.
- K153086: RX ACCUNET Embolic Protection System, Abbott Vascular (2015) Summary page 5.

## Most influential descendants
- K221339: Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection (2022), 0 descendants of its own

## Indications for use
The Paladin System with Integrated Embolic Protection (IEP) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the carotid arteries with capture and removal of embolic material. This device is also indicated for post-dilation of self-expanding stents in the carotid arteries with capture and removal of embolic material. The diameter of the arterial site for filter deployment should be no more than 7.0 mm. The Paladin System with IEP should always be used in conjunction with an available embolic protection device.

Source page: https://510kreport.com/device/K181128
Methodology: https://510kreport.com/methodology