Name: Predicase
Price: 199 USD

K-number	K153213
Device name	Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir
Applicant	Terumo Cardiovascular Systems Corporation
Product code	DTZ
Device class	Class II
Decision date	Dec 3, 2015
Decision	Substantially Equivalent
Regulation	870.4350

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Source

View the full FDA submission: accessdata.fda.gov

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Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir

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