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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, Neurovasculature
510(k) Number K254223
Device Name Next Generation 088 Catheter
Applicant
Balt USA, LLC
29 Parker
Irvine,  CA  92618
Applicant Contact Subha Elango
Correspondent
Balt USA, LLC
29 Parker
Irvine,  CA  92618
Correspondent Contact Subha Elango
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received12/29/2025
Decision Date 04/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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