Medical Device Manufacturer · IE , Galway

Zerusa Limited - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2005

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Zerusa Limited Cardiovascular ✕

4 devices

1-4 of 4

Cleared May 21, 2010

GUARDIAN II NC HEMOSTASIS VALVE

Cardiovascular · 30d

Cleared Oct 01, 2009

GUARDIAN II HEMOSTASIS VALVE

Cardiovascular · 28d

Cleared Feb 27, 2008

GUARDIAN HEMOSTASIS VALVE

Cardiovascular · 63d

Cleared Nov 21, 2005

GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER

Cardiovascular · 83d