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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K230363
Device Name CPS Locator 3D Delivery Catheter
Applicant
CenterPoint Systems, LLC
3338 Pkwy. Blvd.
West Valley City,  UT  84119
Applicant Contact Marybeth Gamber
Correspondent
CenterPoint Systems, LLC
3338 Pkwy. Blvd.
West Valley City,  UT  84119
Correspondent Contact Marybeth Gamber
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/10/2023
Decision Date 03/09/2023
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
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