FDA 510(k) Applications Submitted by Luigi Vecchi
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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 |
| K170460 |
02/15/2017 |
Sorin Connect |
Sorin Group Deutschland GmbH |
| K150489 |
02/25/2015 |
EOS PMP, EOS PMP Integrated |
SORIN GROUP ITALIA S.R.L. |
| K200612 |
03/09/2020 |
R501 aortic root cannula without vent line, R502 aortic root cannula with vent line |
Sorin Group Italia S.r.l. |
| K190650 |
03/13/2019 |
Revolution Centrifugal Blood Pump |
SORIN GROUP ITALIA S.R.L. |
| K200683 |
03/16/2020 |
INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoi |
Sorin Group Italia S.R.L. |
| K190690 |
03/18/2019 |
INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir |
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 |
| K151713 |
06/25/2015 |
LILLIPUP PMP, LILLIPUT PMP INTEGRATED |
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 |
| K223361 |
11/03/2022 |
BMR 1900 PHISIO |
Sorin Group Italia S.R.L. |
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