FDA 510(k) Applications Submitted by DONNA R 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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