# Hemosphere, Inc.

- Location (FDA's records): Eden Prarie, MN
- FDA decisions: 3 (2009–2012): 3 510(k) clearances
- Product codes: DSY (3)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 6 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Graftcath, Inc.: 3 (https://510kreport.com/company/graftcath)

## Firms that cite its devices most
- Hemoshpere, Inc., A Cryolife Company: 3 (https://510kreport.com/company/hemoshpere-a-cryolife)

## Its most-cited devices
- K091491: Hero Vascular Access Device (2009), cited by 3
- K120006: Hero Graft (2012), cited by 2
- K121532: Hero Graft (2012), cited by 1

## Recent decisions
- K121532: Hero Graft (Jun 22, 2012)
- K120006: Hero Graft (Feb 2, 2012)
- K091491: Hero Vascular Access Device (Jul 31, 2009)

Source page: https://510kreport.com/company/hemosphere