MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822— 510(k) K032929

Unknown

Abbott Vascular, Inc.

FDA 510(k) clearance K032929 for MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822, Unknown on 2003-10-22. Applicant: Abbott Vascular, Inc..

Clearance details

Applicant: Abbott Vascular, Inc.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 2003-09-22
Decision date: 2003-10-22
Decision: Unknown
Clearance type: Special
Location: Redwood, CA, 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, 2020-01-01 through 2026-04-23. 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.