HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION— 510(k) K052302
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K052302 for HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION, Substantially Equivalent on 2005-09-12. Applicant: Boston Scientific Corp.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code MAL
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Maple Grove, MN, US
Adverse events under product code MAL
product code MAL- Death
- 4
- Total
- 4
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.