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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 K241243
Device Name Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)
Applicant
Centerline Biomedical, Inc.
10000 Cedar Ave.
Cleveland,  OH  44106
Applicant Contact Amanda Shade
Correspondent
Centerline Biomedical, Inc.
10000 Cedar Ave.
Cleveland,  OH  44106
Correspondent Contact Amanda Shade
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
DQY  
Date Received05/03/2024
Decision Date 07/24/2024
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
Recalls CDRH Recalls
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