BARD HYDROGEL-COATED FOLEY CATHETERS— 510(k) K910195

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K910195 for BARD HYDROGEL-COATED FOLEY CATHETERS, Substantially Equivalent on 1991-08-09. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code EZC
Advisory panel: Gastroenterology, Urology
Date received: 1991-01-16
Decision date: 1991-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Covington, GA, US

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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 →

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