BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF— 510(k) K910846

Name: FDA 510(k) clearance K910846
Creator: U.S. Food and Drug Administration
Published: 1991-08-16

Unknown

C.R. Bard, Inc.

FDA 510(k) clearance K910846 for BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF, Unknown on 1991-08-16. Applicant: C.R. Bard, Inc.. Device class: 2.

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code EZC
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1991-02-27
Decision date: 1991-08-16
Decision: Unknown
Clearance type: Traditional
Location: Covington, GA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EZC

product code EZC

Injury: 772
Malfunction: 6,262
Other: 1
Total: 7,035

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 →

Recalls naming K910846

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K910846.

Data sourced from openFDA. This site is unofficial and independent of the FDA.