PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM— 510(k) K041796

Unknown

Cordis Corporation

FDA 510(k) clearance K041796 for PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM, Unknown on 2004-08-03. Applicant: Cordis Corporation.

Clearance details

Applicant: Cordis Corporation
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 2004-07-02
Decision date: 2004-08-03
Decision: Unknown
Clearance type: Special
Location: Miami Lakes, FL, 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.