MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM— 510(k) K021345
UnknownCordis Corp.
FDA 510(k) clearance K021345 for MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM, Unknown on 2002-06-28. Applicant: Cordis Corp.. Device class: 2.
Clearance details
- Applicant
- Cordis Corp.
- Product code
- Code FGE
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Special
- Location
- Warren, NJ, US
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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.