XTRA Autotransfusion System (with XTRA Bowl sets)— 510(k) K240584

Substantially Equivalent

Sorin Group Italia S.R.L.

FDA 510(k) clearance K240584 for XTRA Autotransfusion System (with XTRA Bowl sets), Substantially Equivalent on 2024-04-29. Applicant: Sorin Group Italia S.R.L..

Clearance details

Applicant: Sorin Group Italia S.R.L.
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 2024-03-01
Decision date: 2024-04-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Mirandola ( Modena), IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAC

product code CAC

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 →

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