510(k) 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)

Substantially Equivalent

Sorin Group Italia S.R.L.

Clearance details

Applicant: Sorin Group Italia S.R.L.
Product code: Code DTR
Advisory panel: Cardiovascular
Date received: 2025-01-21
Decision date: 2025-05-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Mirandola (Modena), IT

Adverse events under product code DTR

product code DTR

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.