K060053

Substantially Equivalent

STOCKERT S5 SYSTEM

Applicant: Sorin Group Deutschland GmbH
Product code: DTQ
Advisory panel: Cardiovascular
Date received: 2006-01-06
Decision date: 2006-06-02
Decision: Substantially Equivalent
Clearance type: Special
Location: North Attleboro, MA, US

Adverse events under product code DTQ

product code DTQ

Death: 123
Malfunction: 4,822
Other: 1
Total: 4,946

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.