# Endocardial Solutions, Inc.

- Location (FDA's records): St. Paul, MN
- FDA decisions: 8 (1999–2004): 8 510(k) clearances
- Product codes: DQK (5), MTD (2), DRB (1)
- Predicates its devices cite: 4 (4 its own); citations of its devices by later devices: 8 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- St Jude Medical: 1 (https://510kreport.com/company/st-jude-medical)
- St. Jude Medical, Inc.-Endocardial Solutions: 1 (https://510kreport.com/company/st-jude-medical-endocardial-solutions)
- N Spine, Inc.: 1 (https://510kreport.com/company/n-spine)
- Ep Technologies, Inc.: 1 (https://510kreport.com/company/ep-technologies)

## Its most-cited devices
- K001437: Ensite 3000 System, Model EE3000 (2000), cited by 3
- K030129: Modification to Ensite 3000 System, Model EE3000 (2003), cited by 2
- K042493: Ensite System, Model EE3000 (2004), cited by 1
- K983456: Ensite 3000 System (1999), cited by 1
- K012926: Modification to Ensite 3000 System, Model EE3000 (2001), cited by 1

## Recent decisions
- K042493: Ensite System, Model EE3000 (Oct 15, 2004)
- K033211: Ensite System (Oct 30, 2003)
- K030129: Modification to Ensite 3000 System, Model EE3000 (Apr 22, 2003)
- K012926: Modification to Ensite 3000 System, Model EE3000 (Sep 28, 2001)
- K001437: Ensite 3000 System, Model EE3000 (Jun 7, 2000)
- K993376: Enstylet Models EC0010, EC0020 (Jan 5, 2000)
- K992479: Ensite 3000 System (Dec 2, 1999)
- K983456: Ensite 3000 System (Apr 21, 1999)

Source page: https://510kreport.com/company/endocardial-solutions