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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 K242133
Device Name Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)
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  
Date Received07/22/2024
Decision Date 10/11/2024
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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