SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE— 510(k) K103762

Substantially Equivalent

Sorin Group Deutschland GmbH

FDA 510(k) clearance K103762 for SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE, Substantially Equivalent on 2011-01-20. Applicant: Sorin Group Deutschland GmbH.

Clearance details

Applicant: Sorin Group Deutschland GmbH
Product code: Code DTQ
Advisory panel: Cardiovascular
Date received: 2010-12-23
Decision date: 2011-01-20
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.