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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 K221057
Device Name Viatrac 14 Plus Peripheral Dilatation Catheter
Applicant
Abbott Vascular
3200 Lakeside Drive
Santa Clara,  CA  95054
Applicant Contact Jiyoung Dang
Correspondent
Abbott Vascular
3200 Lakeside Drive
Santa Clara,  CA  95054
Correspondent Contact Jiyoung Dang
Regulation Number870.1250
Classification Product Code
LIT  
Date Received04/11/2022
Decision Date 05/05/2022
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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