FDA.report

510(k) K250150

Device
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)
Applicant
Sorin Group Italia S.R.L.
510(k) number
K250150
Product code
DTR
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-30
Date received
2025-01-21
Regulation
870.4240
Classification name
Heat-Exchanger, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Martina Carlini
Address
Via Statale 12 Nord, 86 Mirandola (Modena) IT 41037 41037

FDA Registration Numbers

Source Documents

510(k) summary PDF

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