Bard RiteCath Intermittent Urinary Catheter— 510(k) K142575

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K142575 for Bard RiteCath Intermittent Urinary Catheter, Substantially Equivalent on 2014-10-31. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code EZD
Advisory panel: Gastroenterology, Urology
Date received: 2014-09-12
Decision date: 2014-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Covington, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZD

product code EZD

Injury: 864
Malfunction: 2,210
Total: 3,074

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.