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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 K203365
Device Name Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter
Applicant
Shockwave Medical., Inc.
5403 Betsy Ross Dr.
Santa Clara,  CA  95054
Applicant Contact Danica Van
Correspondent
Shockwave Medical., Inc.
5403 Betsy Ross Dr.
Santa Clara,  CA  95054
Correspondent Contact Danica Van
Regulation Number870.1250
Classification Product Code
PPN  
Date Received11/16/2020
Decision Date 04/22/2021
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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