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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
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