MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER— 510(k) K982970

Substantially Equivalent

Mri Manufacturing and Research, Inc.

FDA 510(k) clearance K982970 for MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER, Substantially Equivalent on 1998-10-28. Applicant: Mri Manufacturing and Research, Inc..

Clearance details

Applicant: Mri Manufacturing and Research, Inc.
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 1998-08-25
Decision date: 1998-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Port Riche, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

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.