HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT— 510(k) K033477

Substantially Equivalent

Rochester Medical Corp.

FDA 510(k) clearance K033477 for HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT, Substantially Equivalent on 2004-06-10. Applicant: Rochester Medical Corp..

Clearance details

Applicant: Rochester Medical Corp.
Product code: Code MJC
Advisory panel: Gastroenterology, Urology
Date received: 2003-11-03
Decision date: 2004-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stewartville, MN, US

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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.