FDA 510(k) Applications Submitted by Martina Carlini

FDA 510(k) Number Submission Date Device Name Applicant
K250150 01/21/2025 VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) Sorin Group Italia S.r.l.
K241236 05/02/2024 XTRA Collection sets; XTRA Sequestration set X Sorin Group Italia S.r.l.
K242953 09/25/2024 KIDS Arterial Filters Sorin Group Italia S.r.l.
K243264 10/15/2024 DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) Sorin Group Italia S.r.l.


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