15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706— 510(k) K040992

Unknown

Medcomp

FDA 510(k) clearance K040992 for 15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706, Unknown on 2004-07-29. Applicant: Medcomp.

Clearance details

Applicant: Medcomp
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2004-04-16
Decision date: 2004-07-29
Decision: Unknown
Clearance type: Traditional
Location: Harleysville, PA, US

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Adverse events under product code MSD

product code MSD

Death: 67
Injury: 545
Malfunction: 3,661
Total: 4,273

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.