Name: Predicase
Price: 199 USD

K-number	K203024
Device name	C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
Applicant	Pentax of America, Inc.
Product code	GEH
Device class	Class II
Decision date	Nov 24, 2020
Decision	Substantially Equivalent
Regulation	878.4350

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Source

View the full FDA submission: accessdata.fda.gov

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C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge

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