K250150

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)

510(k) number: K250150
Device name: 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. IT
Product code: DTR — Heat-Exchanger, Cardiopulmonary Bypass
Decision date: 2025-05-30
Date received: 2025-01-21
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: Cardiovascular

PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K250150.pdf

Official FDA record: K250150

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.