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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 K261329
Device Name Intra-Operative Positioning System (IOPS) (MC-1);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
4535 Renaissance Pkwy.
Warrensville Heights,  OH  44128
Applicant Contact Carroll Martin
Correspondent
Centerline Biomedical
4535 Renaissance Pkwy.
Warrensville Heights,  OH  44128
Correspondent Contact Carroll L. Martin
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Codes
DQX   DQY  
Date Received04/22/2026
Decision Date 06/10/2026
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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