1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER— 510(k) K000793

Substantially Equivalent

Guidant Corp.

FDA 510(k) clearance K000793 for 1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER, Substantially Equivalent on 2000-04-12. Applicant: Guidant Corp..

Clearance details

Applicant: Guidant Corp.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 2000-03-13
Decision date: 2000-04-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Temecula, CA, US

Download summary PDF View on FDA.gov ↗

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.