XTRA— 510(k) K112245

Clearance details

Applicant

Sorin Group Italia S.R.L.

Product code

Code CAC

Device class

Class 2

Regulation

21 CFR 868.5830

Advisory panel

Anesthesiology

Date received

2011-08-04

Decision date

2011-09-06

Decision

Substantially Equivalent

Clearance type

Special

Location

Waltham, MA, US

• K241236 — XTRA Collection sets; XTRA Sequestration set X2024-08-16
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• K240584 — XTRA Autotransfusion System (with XTRA Bowl sets)2024-04-29
• K231782 — FlowSaver Blood Return System (80-101)2023-07-14
• K221483 — FlowSaver Blood Return System2023-02-17

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• 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

11

Malfunction

477

Total

488

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 →