K971627

Substantially Equivalent

SILICONE ANTIBACTERIAL FOLEY CATHETER

Applicant: Rochester Medical Corp.
Product code: MJC
Advisory panel: Gastroenterology, Urology
Date received: 1997-05-02
Decision date: 1998-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stewartville, MN, US

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.