BARDEX LUBRI-SIL I.C. FOLEY CATHETER— 510(k) K984136

Substantially Equivalent

Bard Medical Div.

FDA 510(k) clearance K984136 for BARDEX LUBRI-SIL I.C. FOLEY CATHETER, Substantially Equivalent on 1999-02-16. Applicant: Bard Medical Div..

Clearance details

Applicant: Bard Medical Div.
Product code: Code MJC
Advisory panel: Gastroenterology, Urology
Date received: 1998-11-18
Decision date: 1999-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Covington, GA, US

Download summary PDF View on FDA.gov ↗

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.