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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 K262201
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 Eric Fang
Correspondent
Shockwave Medical, Inc.
5403 Betsy Ross Dr.
Santa Clara,  CA  95054
Correspondent Contact Eric Fang
Regulation Number870.1250
Classification Product Code
PPN  
Date Received06/29/2026
Decision Date 07/27/2026
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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