LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM— 510(k) K130792

Unknown

C.R. Bard, Inc.

FDA 510(k) clearance K130792 for LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM, Unknown on 2013-08-30. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 2013-03-22
Decision date: 2013-08-30
Decision: Unknown
Clearance type: Traditional
Location: Tempe, AZ, 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.