VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT— 510(k) K092486

Substantially Equivalent

Vortex Medical, Inc.

FDA 510(k) clearance K092486 for VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT, Substantially Equivalent on 2009-08-28. Applicant: Vortex Medical, Inc..

Clearance details

Applicant: Vortex Medical, Inc.
Product code: Code DWE
Advisory panel: Cardiovascular
Date received: 2009-08-13
Decision date: 2009-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glens Falls, NY, US

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Adverse events under product code DWE

product code DWE

Death: 9
Malfunction: 754
Total: 763

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.