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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K212490
Device Name AVVIGO Guidance System II
Applicant
Boston Scientific Corporation
Three Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact Margaret Batchelder
Correspondent
Boston Scientific Corporation
Three Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact Margaret Batchelder
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Codes
DSK   ITX   IYO  
Date Received08/09/2021
Decision Date 10/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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