CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM— 510(k) K012590

Unknown

Cordis Corp.

FDA 510(k) clearance K012590 for CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM, Unknown on 2001-09-07. Applicant: Cordis Corp..

Clearance details

Applicant: Cordis Corp.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 2001-08-10
Decision date: 2001-09-07
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, 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.