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
K161733 06/23/2016 INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C 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


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