K964780

Substantially Equivalent

BARD DIRECTOR GUIDEWIRE (000560)

Applicant: C.R. Bard, Inc.
Product code: OCY
Advisory panel: Gastroenterology, Urology
Date received: 1996-11-27
Decision date: 1997-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, MA, US

Adverse events under product code OCY

product code OCY

Injury: 186
Malfunction: 578
Total: 764

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.