BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24— 510(k) K983101

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K983101 for BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24, Substantially Equivalent on 1998-11-03. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code MJC
Advisory panel: Gastroenterology, Urology
Date received: 1998-09-03
Decision date: 1998-11-03
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Covington, GA, US

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Adverse events under product code MJC

product code MJC

Injury: 398
Malfunction: 12,582
Other: 2
Total: 12,982

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.