MODIFICATION TO STOCKERT S5 SYSTEM— 510(k) K062396

Substantially Equivalent

Sorin Group Deutschland GmbH

FDA 510(k) clearance K062396 for MODIFICATION TO STOCKERT S5 SYSTEM, Substantially Equivalent on 2006-09-28. Applicant: Sorin Group Deutschland GmbH.

Clearance details

Applicant: Sorin Group Deutschland GmbH
Product code: Code DTQ
Advisory panel: Cardiovascular
Date received: 2006-08-16
Decision date: 2006-09-28
Decision: Substantially Equivalent
Clearance type: Special
Location: North Attleboro, MA, US

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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.