K092486
Substantially EquivalentVORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT
- Applicant
- Vortex Medical, Inc.
- Product code
- DWE
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Glens Falls, NY, US
Adverse events under product code DWE
product code DWE- Death
- 9
- Malfunction
- 754
- Total
- 763
Source: openFDA MAUDE database, through . 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.