# P230013: Edwards EVOQUE Tricuspid Valve Replacement System

- Pathway: PMA
- Applicant: Edwards Lifesciences, LLC
- Decided: Feb 1, 2024 after 307 days
- Product code: NPW (Percutaneously Delivered Prostheses And Tricuspid Valves)
- Device class: 3
- Recalls of this device: 1 (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
- Mar 27, 2026 · Class II · Z-2172-2026: Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.

Source page: https://510kreport.com/device/P230013
Methodology: https://510kreport.com/methodology