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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K121352
Device Name ARMADA 14XXT PTA CATHETER
Applicant
Abbott Vascular
3200 Lakeside Drive
Santa Clara,  CA  95054
Applicant Contact Ivalee Cohen
Correspondent
Abbott Vascular
3200 Lakeside Drive
Santa Clara,  CA  95054
Correspondent Contact Ivalee Cohen
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
LIT  
Date Received05/04/2012
Decision Date 08/15/2012
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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