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FDA 510(k) Applications Submitted by DONNA LUNAK
FDA 510(k) Number
Submission Date
Device Name
Applicant
K093942
12/22/2009
ENSITE VELOCITY SYSTEM V1.3
ST. JUDE MEDICAL
K110549
02/25/2011
ENSITE VELOCITY SYSTEM
ST. JUDE MEDICAL
K130594
03/07/2013
ENSITE VELOCITY SYSTEM
ST. JUDE MEDICAL
K130727
03/18/2013
ENSITE VELOCITY SYSTEM
ST. JUDE MEDICAL
K011152
04/16/2001
VASOTRAC APM205A
MEDWAVE, INC.
K141050
04/23/2014
ENSITE VELOCITY SYSTEM
ST. JUDE MEDICAL
K101328
05/11/2010
ENSITE VELOCITY SYSTEM
ST. JUDE MEDICAL
K101419
05/20/2010
ENSITE VELOCITY SYSTEM, MODEL EE3000
ST. JUDE MEDICAL
K061557
06/05/2006
FUSION
MEDWAVE, INC.
K101667
06/14/2010
ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT)
ST. JUDE MEDICAL
K001898
06/22/2000
VASOTRAX
MEDWAVE, INC.
K082279
08/11/2008
EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2
ST. JUDE MEDICAL
K112688
09/15/2011
ENSITE VELOCITY SYSTEM V.3.0
ST. JUDE MEDICAL
K053185
11/14/2005
PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
MEDWAVE, INC.
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