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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 K254089
Device Name IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)
Applicant
Centerline Biomedical, Inc.
4535 Renaissance Pkwy.
Cleveland,  OH  44128
Applicant Contact Carroll Martin
Correspondent
Centerline Biomedical, Inc.
4535 Renaissance Pkwy.
Cleveland,  OH  44128
Correspondent Contact Carroll Martin
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
DQY  
Date Received12/19/2025
Decision Date 02/17/2026
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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