STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM— 510(k) K101046

Substantially Equivalent

Sorin Group Deutschland GmbH

FDA 510(k) clearance K101046 for STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM, Substantially Equivalent on 2010-12-09. Applicant: Sorin Group Deutschland GmbH.

Clearance details

Applicant: Sorin Group Deutschland GmbH
Product code: Code DTX
Advisory panel: Cardiovascular
Date received: 2010-04-14
Decision date: 2010-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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Adverse events under product code DTX

product code DTX

Death: 3
Malfunction: 497
Total: 500

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.