XTRA Collection sets; XTRA Sequestration set X— 510(k) K241236

Substantially Equivalent

Sorin Group Italia S.R.L.

FDA 510(k) clearance K241236 for XTRA Collection sets; XTRA Sequestration set X, Substantially Equivalent on 2024-08-16. 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: 2024-05-02
Decision date: 2024-08-16
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.