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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 K221041
Device Name Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
Applicant
Shockwave Medical, Inc.
5403 Betsy Ross Dr.
Santa Clara,  CA  95054
Applicant Contact Soraya L Hori
Correspondent
Shockwave Medical, Inc.
5403 Betsy Ross Dr.
Santa Clara,  CA  95054
Correspondent Contact Soraya L Hori
Regulation Number870.1250
Classification Product Code
PPN  
Date Received04/08/2022
Decision Date 04/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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