Name: Predicase
Price: 199 USD

K-number	K180448
Device name	INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter
Applicant	Sorin Group Italia S.R.L.
Product code	DTZ
Device class	Class II
Decision date	Mar 15, 2018
Decision	Substantially Equivalent
Regulation	870.4350

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Source

View the full FDA submission: accessdata.fda.gov

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INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter

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