Shockwave Intravascular Lithotripsy (IVL) System With The Shockwave M5+ Peripheral IVL Catheter

Percutaneous Catheter, Ultrasound

Shockwave Medical, Inc.

The following data is part of a premarket notification filed by Shockwave Medical, Inc. with the FDA for Shockwave Intravascular Lithotripsy (ivl) System With The Shockwave M5+ Peripheral Ivl Catheter.

Pre-market Notification Details

Device IDK203365
510k NumberK203365
Device Name:Shockwave Intravascular Lithotripsy (IVL) System With The Shockwave M5+ Peripheral IVL Catheter
ClassificationPercutaneous Catheter, Ultrasound
Applicant Shockwave Medical, Inc. 5403 Betsy Ross Dr Santa Clara,  CA  95054
ContactDanica Van
CorrespondentDanica Van
Shockwave Medical, Inc. 5403 Betsy Ross Dr Santa Clara,  CA  95054
Product CodePPN  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-16
Decision Date2021-04-22

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