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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 K161384
Device Name Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable
Applicant
Shockwave Medical, Inc.
48501 Warm Springs Blvd.
Suite 108
Fremont,  CA  94539
Applicant Contact NORA HADDING
Correspondent
Shockwave Medical, Inc.
48501 Warm Springs Blvd.
Suite 108
Fremont,  CA  94539
Correspondent Contact NORA HADDING
Regulation Number870.1250
Classification Product Code
PPN  
Date Received05/19/2016
Decision Date 09/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT02369848
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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