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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 K252512
Device Name Armada™ 14 NC PTA Catheter
Applicant
Abbott Medical
3200 Lakeside Dr.
S,Mta Clara,  CA  95054
Applicant Contact Daire Farrell
Correspondent
Abbott Medical
3200 Lakeside Dr.
S,Mta Clara,  CA  95054
Correspondent Contact Daire Farrell
Regulation Number870.1250
Classification Product Code
LIT  
Date Received08/11/2025
Decision Date 02/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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