# K221339: Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection

- Pathway: 510(k) (Special)
- Applicant: Contego Medical, Inc.
- Decided: Jun 9, 2022 after 31 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: 8 generations back to K001134 (2000). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181128: Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System), Contego Medical, LLC (2018) Summary page 4.

## Indications for use
The Paladin Carotid PTA Balloon 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 Carotid PTA Balloon System with Integrated Embolic Protection (IEP) should always be used in conjunction with an available embolic protection device when used for post-dilation of self-expanding stents.

Source page: https://510kreport.com/device/K221339
Methodology: https://510kreport.com/methodology