Nuwellis seeks FDA clearance for Aquadex use in children weighing 5 kg and above

NUWE•2026-11-05

Nuwellis submitted a 510(k) application seeking FDA clearance for Aquadex SmartFlow use in pediatric patients weighing at least 5 kg. The system is currently cleared for patients weighing at least 20 kg.

Nuwellis seeks FDA clearance for Aquadex use in children weighing 5 kg and above

1. FDA application

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