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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 K260199
Device Name SLIM Microcatheter
Applicant
Balt USA, LLC
29 Parker
Irvine,  CA  92618
Applicant Contact Catherine Chiou
Correspondent
Balt USA, LLC
29 Parker
Irvine,  CA  92618
Correspondent Contact Subha Elango
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Codes
DQY   KRA  
Date Received01/22/2026
Decision Date 07/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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