VOYAGER QUAD CANNULA— 510(k) K983270

Substantially Equivalent

Cardiothoracic Systems, Inc.

FDA 510(k) clearance K983270 for VOYAGER QUAD CANNULA, Substantially Equivalent on 1999-07-28. Applicant: Cardiothoracic Systems, Inc..

Clearance details

Applicant: Cardiothoracic Systems, Inc.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 1998-09-17
Decision date: 1999-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cupertino, CA, US

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Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.