510(k) K990631— CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC

Unknown

Cordis Corp.

Clearance details

Applicant: Cordis Corp.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 1999-02-26
Decision date: 1999-04-30
Decision: Unknown
Clearance type: Traditional
Location: Warren, NJ, 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, 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.