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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Percutaneous Catheter, Ultrasound
510(k) Number K250225
Device Name Bolt Intravascular Lithotripsy (IVL) System
Applicant
Bolt Medical, Inc.
2131 Faraday Ave.
Carlsbad,  CA  92008
Applicant Contact Stephanie Onstot
Correspondent
Bolt Medical, Inc.
2131 Faraday Ave.
Carlsbad,  CA  92008
Correspondent Contact Stephanie Onstot
Regulation Number870.1250
Classification Product Code
PPN  
Date Received01/27/2025
Decision Date 03/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT05662787
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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