FDA applicant
Sequana Medical NV
FDA records 1 decision for Sequana Medical NV (Sint-Denijs-Westrem) in 2024: 1 original PMA approval. All are in product code SDQ (Alfapump System). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Sequana Medical NV’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2024high 1 (2024) · low 0 (2025)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Sequana Medical NV’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report