Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator And Connector Cable Kit, IVL Connector Cable (Replacement)

Percutaneous Catheter, Ultrasound

Shockwave Medical, Inc.

The following data is part of a premarket notification filed by Shockwave Medical, Inc. with the FDA for Peripheral Intravascular Lithotripsy (ivl) Catheters, Ivl Generator And Connector Cable Kit, Ivl Connector Cable (replacement).

Pre-market Notification Details

Device IDK191840
510k NumberK191840
Device Name:Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator And Connector Cable Kit, IVL Connector Cable (Replacement)
ClassificationPercutaneous Catheter, Ultrasound
Applicant Shockwave Medical, Inc. 5403 Betsy Ross Drive Santa Clara,  CA  95054
ContactCindy Morrow
CorrespondentCindy Morrow
Shockwave Medical, Inc. 5403 Betsy Ross Drive Santa Clara,  CA  95054
Product CodePPN  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-09
Decision Date2019-08-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00195451000072 K191840 000
00195451000065 K191840 000
00195451000058 K191840 000
00195451000041 K191840 000
00195451000300 K191840 000
00195451000294 K191840 000
00195451000461 K191840 000

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