EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM— 510(k) K024303
UnknownEdwards Lifesciences, LLC
FDA 510(k) clearance K024303 for EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM, Unknown on 2003-07-03. Applicant: Edwards Lifesciences, LLC.
Clearance details
- Applicant
- Edwards Lifesciences, LLC
- Product code
- Code FGE
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Adverse events under product code FGE
product code FGE- Death
- 52
- Injury
- 2,347
- Malfunction
- 9,798
- Other
- 1
- Total
- 12,198
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.