K-number	K153143
Device name	Capiox Advance Hardshell Reservoir
Applicant	Terumo Cardiovascular Systems Corporation
Product code	DTN
Device class	Class II
Decision date	Dec 2, 2015
Decision	Substantially Equivalent
Regulation	870.4400

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View the full FDA submission: accessdata.fda.gov

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Capiox Advance Hardshell Reservoir

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