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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, angioplasty, peripheral, transluminal
510(k) Number K102705
Device Name ARMADA 14 PTA CATHETER
Applicant
ABBOTT VASCULAR INC.
3200 LAKESIDE DRIVE
SANTA CLARA,  CA  92054
Applicant Contact LAARNI RICAFORT
Correspondent
ABBOTT VASCULAR INC.
3200 LAKESIDE DRIVE
SANTA CLARA,  CA  92054
Correspondent Contact LAARNI RICAFORT
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received09/20/2010
Decision Date 12/07/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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