# Hjarta Care, LLC

- Location (FDA's records): Waukesha, WI
- FDA decisions: 1 (2026–2026): 1 De Novo grant
- Product codes: SHR (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- DEN250033: XplantR Explant Tool (Apr 17, 2026)

Source page: https://510kreport.com/company/hjarta-care