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Sorin Group Italia S.R.L.

FDA 510(k) & PMA Approved Devices — 24 products

Total Devices24
Categories10
Latest FDA decision2026-01-30
TypeNumberDevice NameCodeDateActions
510(k) K180411 MEMO 4DKRH2018-03-16 View
510(k) K180448 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 FilterDTZ2018-03-15 View
510(k) K162215 Aortic Arch Cannulae, Optiflow Aortic Arch CannulaeDWF2017-06-16 View
510(k) K161733 INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F CDTN2017-03-08 View

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