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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheters, transluminal coronary angioplasty, percutaneous
510(k) Number K121222
Device Name TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER
Original Applicant
ABBOTT VASCULAR
26531 ynez road
p.o. box 9018
temecula,  CA  92589 9018
Original Contact suzanne redman
Regulation Number870.5100
Classification Product Code
LOX  
Date Received04/25/2012
Decision Date 06/22/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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