K112245

Substantially Equivalent

XTRA

Applicant: Sorin Group Italia S.R.L.
Product code: CAC
Advisory panel: Anesthesiology
Date received: 2011-08-04
Decision date: 2011-09-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Waltham, MA, US

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.