Name: Predicase
Price: 199 USD

K-number	K151389
Device name	Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir
Applicant	Terumo Cardiovascular Systems Corporation
Product code	DTZ
Device class	Class II
Decision date	Oct 20, 2015
Decision	Substantially Equivalent
Regulation	870.4350

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Source

View the full FDA submission: accessdata.fda.gov

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Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir

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