Name: Predicase
Price: 199 USD

K-number	K242213
Device name	Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter
Applicant	Shockwave Medical, Inc.
Product code	PPN
Device class	Class II
Decision date	Sep 27, 2024
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter

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