Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, Lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable

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 M5 Peripheral Intravascular Lithotripsy (ivl) Catheter, Lntravascular Lithotripsy (ivl) Generator And Connector Cable, Intravascular Lithotripsy (ivl) Connector Cable.

Pre-market Notification Details

Device IDK180958
510k NumberK180958
Device Name:Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, Lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable
ClassificationPercutaneous Catheter, Ultrasound
Applicant Shockwave Medical, Inc. 48501 Warm Springs Blvd, Suite 108 Fremont,  CA  94539
ContactCindy Morrow
CorrespondentCindy Morrow
Shockwave Medical, Inc. 48501 Warm Springs Blvd, Suite 108 Fremont,  CA  94539
Product CodePPN  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-12
Decision Date2018-07-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00195451000195 K180958 000
00195451000188 K180958 000
00195451000171 K180958 000
00195451000164 K180958 000
00195451000157 K180958 000
00195451000140 K180958 000
00195451000133 K180958 000
00195451000126 K180958 000

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