Name: Predicase
Price: 199 USD

K-number	K191840
Device name	Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)
Applicant	Shockwave Medical, Inc.
Product code	PPN
Device class	Class II
Decision date	Aug 7, 2019
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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

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