CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS— 510(k) K991674

Unknown

Cordis Corp.

FDA 510(k) clearance K991674 for CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS, Unknown on 1999-08-12. Applicant: Cordis Corp..

Clearance details

Applicant: Cordis Corp.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 1999-05-17
Decision date: 1999-08-12
Decision: Unknown
Clearance type: Traditional
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, 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.