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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 K250492
Device Name FlexiGo 3D Delivery Catheter
Applicant
CenterPoint Systems, LLC
3338 Pkwy. Blvd.
West Valley City,  UT  84119
Applicant Contact Conner Johnson
Correspondent
CenterPoint Systems, LLC
3338 Pkwy. Blvd.
West Valley City,  UT  84119
Correspondent Contact Conner Johnson
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/20/2025
Decision Date 06/18/2025
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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