CATHETER, SILICONE FOLEY (BARDEX)— 510(k) K760093

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K760093 for CATHETER, SILICONE FOLEY (BARDEX), Substantially Equivalent on 1976-08-23. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code GBM
Advisory panel: Gastroenterology, Urology
Date received: 1976-06-21
Decision date: 1976-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GBM

product code GBM

Injury: 397
Malfunction: 1,404
Total: 1,801

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.