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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 K230884
Device Name AVVIGO'+ Multi-Modality Guidance System
Applicant
Boston Scientific Corporation
Two Scimed Place
Maple Grove,  MN  55311
Applicant Contact Kevin Catalano
Correspondent
Boston Scientific Corporation
Two Scimed Place
Maple Grove,  MN  55311
Correspondent Contact Kevin Catalano
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Codes
DSK   ITX   IYO  
Date Received03/30/2023
Decision Date 09/26/2023
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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