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Zerusa Limited
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K101113
GUARDIAN II NC HEMOSTASIS VALVE
May 21, 2010
K092711
GUARDIAN II HEMOSTASIS VALVE
October 1, 2009
K073620
GUARDIAN HEMOSTASIS VALVE
February 27, 2008
K052381
GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER
November 21, 2005