VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002— 510(k) K022718
Substantially EquivalentGuidant Corporation, Cardiac Surgery
FDA 510(k) clearance K022718 for VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002, Substantially Equivalent on 2002-08-28. Applicant: Guidant Corporation, Cardiac Surgery.
Clearance details
- Applicant
- Guidant Corporation, Cardiac Surgery
- Product code
- Code GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.