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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Neurovascular Embolization
510(k) Number K254221
Device Name Optima Coil System (OptiOne Coil System)
Applicant
Balt USA, LLC
29 Parker
Irvine,  CA  92618
Applicant Contact Kavita Chandrashekar
Correspondent
Balt USA, LLC
29 Parker
Irvine,  CA  92618
Correspondent Contact Kavita Chandrashekar
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received12/29/2025
Decision Date 01/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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