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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 K151317
Device Name Armada 18 PTA Catheter
Applicant
ABBOTT VASCULAR
3200 LAKESIDE DR
SANTA CLARA,  CA  95054
Applicant Contact Shu Chi Hsu
Correspondent
ABBOTT VASCULAR
3200 LAKESIDE DR
SANTA CLARA,  CA  95054
Correspondent Contact Shu Chi Hsu
Regulation Number870.1250
Classification Product Code
LIT  
Date Received05/18/2015
Decision Date 07/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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