# P240029: CGuard Prime Carotid Stent System

- Pathway: PMA
- Applicant: InspireMD, Ltd.
- Decided: Jun 23, 2025 after 280 days
- Product code: NIM (Stent, Carotid)
- Device class: 3
- Recalls of this device: 6 (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
- May 1, 2026 · Class II · Z-2328-2026: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- May 1, 2026 · Class II · Z-2330-2026: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- May 1, 2026 · Class II · Z-2326-2026: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- May 1, 2026 · Class II · Z-2329-2026: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- May 1, 2026 · Class II · Z-2327-2026: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- May 1, 2026 · Class II · Z-2325-2026: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

Source page: https://510kreport.com/device/P240029
Methodology: https://510kreport.com/methodology