R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26)— 510(k) K240193

Clearance details

Applicant

Sorin Group Italia S.R.L.

Product code

Product code DWF

Device class

Class 2

Regulation

21 CFR 870.4210

Advisory panel

Cardiovascular

Date received

2024-01-24

Decision date

2024-02-22

Decision

Substantially Equivalent

Clearance type

Special

Location

Mirandola ( Modena), IT

• K263092 — Dual Stage Venous Cannulae2026-10-01
• K262052 — Tri Stage Venous Cannulae2026-09-28
• K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae2026-04-23
• K250937 — Venous Return Cannulae2026-03-11
• K260043 — Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)2026-02-23

• K253671 — Dual Stage Venous Cannulae2026-01-30
• K251783 — Inspire HCR and HCR DUAL cardiotomy reservoirs2025-12-22
• K253616 — ProtekDilate Vascular Access Kit2025-12-19
• K250610 — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)2025-06-27
• K250150 — VANGUARD Blood cardioplegia Systems (3 models)2025-05-30

Death

106

Injury

386

Malfunction

2,323

Total

2,815

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 →