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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 K230309
Device Name Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1)
Applicant
Centerline Biomedical, Inc.
1000 Cedar Ave.
Cleveland,  OH  44106
Applicant Contact Amanda Shade
Correspondent
Centerline Biomedical, Inc.
1000 Cedar Ave.
Cleveland,  OH  44106
Correspondent Contact Amanda Shade
Regulation Number870.1425
Classification Product Code
DQK  
Date Received02/03/2023
Decision Date 06/21/2023
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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