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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 K240225
Device Name Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
Applicant
Shockwave Medical., Inc.
5403 Betsy Ross Dr.
Santa Clara,  CA  95054
Applicant Contact Anna Bushart
Correspondent
Shockwave Medical., Inc.
5403 Betsy Ross Dr.
Santa Clara,  CA  95054
Correspondent Contact Anna Bushart
Regulation Number870.1250
Classification Product Code
PPN  
Date Received01/26/2024
Decision Date 03/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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