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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 K252441
Device Name Primero Safe Access System
Applicant
South53, LLC
27131 Calle Arroyo, Suite 1722
San Juan Capistrano,  CA  92675
Applicant Contact Rodney Brenneman
Correspondent
Biologics and Medical Device Consulting Group (Biomdg)
930 Tahoe Blvd. Suite 802 Pmb 323
Incline Village,  NV  89451
Correspondent Contact Octavio Cruz-Uribe
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/04/2025
Decision Date 09/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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