RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER— 510(k) K001143

Substantially Equivalent

Rochester Medical Corp.

FDA 510(k) clearance K001143 for RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER, Substantially Equivalent on 2000-07-07. Applicant: Rochester Medical Corp..

Clearance details

Applicant: Rochester Medical Corp.
Product code: Code MJC
Advisory panel: Gastroenterology, Urology
Date received: 2000-04-10
Decision date: 2000-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stewartville, MN, 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.