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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K242106
Device Name AuST Steerable Sheath
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 Number870.1340
Classification Product Code
DYB  
Subsequent Product Code
DRA  
Date Received07/18/2024
Decision Date 10/04/2024
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
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