# P240009: Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection

- Pathway: PMA
- Applicant: Contego Medical, Inc.
- Decided: Oct 11, 2024 after 196 days
- Product code: NIM (Stent, Carotid)
- Device class: 3
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jun 29, 2026 · Class II · Z-2911-2026: Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction
- Sep 4, 2025 · Class II · Z-0131-2026: Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during sheath retraction and operation of the 

Source page: https://510kreport.com/device/P240009
Methodology: https://510kreport.com/methodology