Name: Predicase
Price: 199 USD

K-number	K181128
Device name	Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)
Applicant	Contego Medical, LLC
Product code	LIT
Device class	Class II
Decision date	Sep 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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Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)

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