Name: Predicase
Price: 199 USD

K-number	K221852
Device name	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
Applicant	Shockwave Medical, Inc.
Product code	PPN
Device class	Class II
Decision date	Aug 16, 2022
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 Shockwave L6 Peripheral IVL Catheter

Everything you need for a 510(k) submission. Nothing you don't.