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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 K230609
Device Name NG Delivery Catheter
Applicant
Balt USA, LLC
29 Parker
Irvine,  CA  92618
Applicant Contact Catherine Chiou
Correspondent
Balt USA, LLC
29 Parker
Irvine,  CA  92618
Correspondent Contact Catherine Chiou
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received03/06/2023
Decision Date 09/13/2023
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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