Name: Predicase
Price: 199 USD

K-number	K161384
Device name	Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable
Applicant	Shockwave Medical, Inc.
Product code	PPN
Device class	Class II
Decision date	Sep 14, 2016
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable

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