# Zerusa Limited

- Location (FDA's records): Galway, IE
- FDA decisions: 4 (2005–2010): 4 510(k) clearances
- Product codes: DTL (4)
- Predicates its devices cite: 6 (4 its own); citations of its devices by later devices: 7 (4 its own)
- Recalls linked to its devices: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Guidant Corp.: 1 (https://510kreport.com/company/guidant)
- Millimed A/S: 1 (https://510kreport.com/company/millimed-a-s)

## Firms that cite its devices most
- Vascular Solutions, Inc.: 2 (https://510kreport.com/company/vascular-solutions)
- Vascular Solutions Zerusa, Ltd.: 1 (https://510kreport.com/company/vascular-solutions-zerusa)

## Its most-cited devices
- K092711: Guardian II Hemostasis Valve (2009), cited by 3
- K073620: Guardian Hemostasis Valve (2008), cited by 2
- K052381: Guardian Hemostasis Valve with Guidewire Introducer (2005), cited by 2

## Recent decisions
- K101113: Guardian II NC Hemostasis Valve (May 21, 2010)
- K092711: Guardian II Hemostasis Valve (Oct 1, 2009)
- K073620: Guardian Hemostasis Valve (Feb 27, 2008)
- K052381: Guardian Hemostasis Valve with Guidewire Introducer (Nov 21, 2005)

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