BARD DIRECTOR GUIDEWIRE (000560)— 510(k) K964780

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K964780 for BARD DIRECTOR GUIDEWIRE (000560), Substantially Equivalent on 1997-02-26. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: 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

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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.