SORIN FLEXTHERM— 510(k) K140012

Substantially Equivalent

Sorin Group Deutschland GmbH

FDA 510(k) clearance K140012 for SORIN FLEXTHERM, Substantially Equivalent on 2014-01-31. Applicant: Sorin Group Deutschland GmbH.

Clearance details

Applicant: Sorin Group Deutschland GmbH
Product code: Code DWC
Advisory panel: Cardiovascular
Date received: 2014-01-02
Decision date: 2014-01-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Arvada, CO, US

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Adverse events under product code DWC

product code DWC

Death: 124
Injury: 233
Malfunction: 3,727
Total: 4,084

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.