VANGUARD Blood cardioplegia Systems (3 models)— 510(k) K250150
Substantially EquivalentSorin Group Italia S.R.L.
FDA 510(k) clearance K250150 for VANGUARD Blood cardioplegia Systems (3 models), Substantially Equivalent on 2025-05-30. Applicant: Sorin Group Italia S.R.L.. Device class: 2.
Clearance details
- Device name as filed
- 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.
- Product code
- Code DTR
- Device class
- Class 2
- Regulation
- 21 CFR 870.4240
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mirandola (Modena), IT
Recent devices under product code DTR
view all- K252541 — Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
- K240908 — Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)
- K240190 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
- K223879 — Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
- K220110 — Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger
More clearances from Sorin Group Italia S.R.L.
view all- K253671 — Dual Stage Venous Cannulae
- K251783 — Inspire HCR and HCR DUAL cardiotomy reservoirs
- K253616 — ProtekDilate Vascular Access Kit
- K250610 — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
- K243264 — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)
Adverse events under product code DTR
product code DTR- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . 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.