VITALCARE URETHRAL CATHETER RED RUBBER— 510(k) K023872

Substantially Equivalent

Vitalcare, Inc.

FDA 510(k) clearance K023872 for VITALCARE URETHRAL CATHETER RED RUBBER, Substantially Equivalent on 2003-04-10. Applicant: Vitalcare, Inc..

Clearance details

Applicant: Vitalcare, Inc.
Product code: Code EZD
Advisory panel: Gastroenterology, Urology
Date received: 2002-11-20
Decision date: 2003-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.