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FDA 510(k) Applications Submitted by KAY SETZER
FDA 510(k) Number
Submission Date
Device Name
Applicant
K101011
04/12/2010
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL
ABBOTT VASCULAR INC.
K101116
04/21/2010
HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH
ABBOTT VASCULAR-CARDIAC THERAPIES
K122573
08/23/2012
HI-TORQUE COMMAND GUIDE WIRE FAMILY
ABBOTT VASCULAR INC.
K112957
10/04/2011
HI-TORQUE POWERTURN
ABBOTT VASCULAR-CARDIAC THERAPIES
K103101
10/20/2010
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE
ABBOTT VASCULAR-CARDIAC THERAPIES
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