Name: Predicase
Price: 199 USD

K-number	K181529
Device name	Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection
Applicant	Contego Medical, LLC
Product code	LIT
Device class	Class II
Decision date	Dec 6, 2018
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection

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