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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 K111899
Device Name ARMADA 35/35LL PTA CATHETER
Applicant
Abbott Vascular
3200 Lakeside Drive
Santa Clara,  CA  95054
Applicant Contact LAARNI RICAFORT
Correspondent
Abbott Vascular
3200 Lakeside Drive
Santa Clara,  CA  95054
Correspondent Contact LAARNI RICAFORT
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received07/05/2011
Decision Date 10/03/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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