# Creganna-Tactx Medical

- Location (FDA's records): Galway, IE
- FDA decisions: 2 (2011–2014): 2 510(k) clearances
- Product codes: DYB (1), LOX (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Edwards Lifesciences, LLC: 1 (https://510kreport.com/company/edwards-lifesciences)
- Cordis Corp.: 1 (https://510kreport.com/company/cordis)
- Scimed Life Systems, Inc.: 1 (https://510kreport.com/company/scimed-life-systems)

## Firms that cite its devices most
- Trireme Medical, Inc.: 2 (https://510kreport.com/company/trireme-medical)
- Intuit Medical, LLC: 1 (https://510kreport.com/company/intuit-medical)
- Lepu Medical Technology (Beijing) Co., Ltd.: 1 (https://510kreport.com/company/lepu-medical-technology-beijing)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- Meril Life Sciences Private Limited: 1 (https://510kreport.com/company/meril-life-sciences-private)

## Its most-cited devices
- K110133: Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation Catheter (2011), cited by 5
- K140338: Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer Set (Large) (2014), cited by 1

## Recent decisions
- K140338: Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer Set (Large) (Aug 27, 2014)
- K110133: Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation Catheter (Jun 10, 2011)

Source page: https://510kreport.com/company/creganna-tactx-medical