# P150011: Perceval Sutureless Heart Valve

- Pathway: PMA
- Applicant: Corcym S.r.l.
- Decided: Jan 8, 2016 after 312 days
- Product code: LWR (Heart-Valve, Non-Allograft Tissue)
- 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
- Oct 31, 2016 · Class II · Z-0716-2017: Sorin Group USA, Inc. announces a voluntary field action for the Perceval Sutureless Heart Valve due to updated steps associated with the implantation procedure.

Source page: https://510kreport.com/device/P150011
Methodology: https://510kreport.com/methodology