RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM— 510(k) K992319

Unknown

Guidant Corp.

FDA 510(k) clearance K992319 for RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM, Unknown on 1999-10-08. Applicant: Guidant Corp..

Clearance details

Applicant: Guidant Corp.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 1999-07-12
Decision date: 1999-10-08
Decision: Unknown
Clearance type: Traditional
Location: Santa Clara, CA, 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.