Name: Predicase
Price: 199 USD

K-number	K153140
Device name	Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating
Applicant	Terumo Cardiovascular Systems Corp.
Product code	DTZ
Device class	Class II
Decision date	Dec 2, 2015
Decision	Substantially Equivalent
Regulation	870.4350

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View the full FDA submission: accessdata.fda.gov

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Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating

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