Cleared Special

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)

K250150 · Sorin Group Italia S.R.L. · Cardiovascular
May 2025
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K250150 is an FDA 510(k) clearance for the 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), a Heat-exchanger, Cardiopulmonary Bypass (Class II — Special Controls, product code DTR), submitted by Sorin Group Italia S.R.L. (Mirandola (Modena), IT). The FDA issued a Cleared decision on May 30, 2025, 129 days after receiving the submission on January 21, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4240.

Submission Details

510(k) Number K250150 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 2025
Decision Date May 30, 2025
Days to Decision 129 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTR — Heat-exchanger, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4240

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