Name: Predicase
Price: 199 USD

K-number	K151054
Device name	Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System
Applicant	C2 Therapeutics, Inc.
Product code	GEH
Device class	Class II
Decision date	Jul 7, 2015
Decision	Substantially Equivalent
Regulation	878.4350

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Source

View the full FDA submission: accessdata.fda.gov

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Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System

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