CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR— 510(k) K131179

Substantially Equivalent

Thoratec Corp

FDA 510(k) clearance K131179 for CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR, Substantially Equivalent on 2013-07-18. Applicant: Thoratec Corp.

Clearance details

Applicant: Thoratec Corp
Product code: Code DWA
Advisory panel: Cardiovascular
Date received: 2013-04-25
Decision date: 2013-07-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWA

product code DWA

Death: 15
Malfunction: 1,654
Total: 1,669

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.