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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 K254046
Device Name BosCATH Support Catheter
Applicant
Sonorous NV, Inc.
1 Spectrum Pt.e Dr.
Suite 150
Lake Forest,  CA  92630
Applicant Contact Ryan Kenney
Correspondent
Sonorous NV, Inc.
1 Spectrum Pointe Dr.
Suite 150
Lake Forest,  CA  92630
Correspondent Contact Erik Mulchandani
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received12/17/2025
Decision Date 04/21/2026
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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