FDA 510(k) Applications Submitted by SORIN GROUP ITALIA S.R.L

FDA 510(k) Number	Submission Date	Device Name	Applicant
K100507	02/22/2010	XRES BLOOD COLLECTION RESERVOIR	SORIN GROUP ITALIA S.R.L
K112245	08/04/2011	XTRA	SORIN GROUP ITALIA S.R.L
K063255	10/27/2006	D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED	SORIN GROUP ITALIA S.R.L
K180448	02/13/2018	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	Sorin Group Italia S.r.l
K180979	04/13/2018	PureFlex Arterial Cannulae	Sorin Group Italia S.r.l
K211495	05/13/2021	EOS PMP	Sorin Group Italia S.R.L
K161733	06/23/2016	INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C	Sorin Group Italia S.r.l
K201916	07/10/2020	Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator	Sorin Group Italia S.r.l
K162215	08/08/2016	Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae	SORIN GROUP ITALIA S.R.L
K142221	08/12/2014	MEMO 3D ReChord	SORIN GROUP ITALIA S.R.L