Shockwave Intravascular Lithotripsy (IVL) System With The Shockwave L6 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 L6 Peripheral Ivl Catheter.

Pre-market Notification Details

Device IDK221852
510k NumberK221852
Device Name:Shockwave Intravascular Lithotripsy (IVL) System With The Shockwave L6 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 Received2022-06-27
Decision Date2022-08-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00195451000416 K221852 000
00195451000409 K221852 000
00195451000393 K221852 000
00195451000386 K221852 000

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