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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 K180958
Device Name Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable
Applicant
Shockwave Medical., Inc.
48501 Warm Springs Blvd., Suite 108
Fremont,  CA  94539
Applicant Contact Cindy Morrow
Correspondent
Shockwave Medical., Inc.
48501 Warm Springs Blvd., Suite 108
Fremont,  CA  94539
Correspondent Contact Cindy Morrow
Regulation Number870.1250
Classification Product Code
PPN  
Date Received04/12/2018
Decision Date 07/26/2018
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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