COMBICATH CATHETER— 510(k) K974642

Substantially Equivalent

Plastimed Laboratoire Pharmaceutique

FDA 510(k) clearance K974642 for COMBICATH CATHETER, Substantially Equivalent on 1998-03-13. Applicant: Plastimed Laboratoire Pharmaceutique.

Clearance details

Applicant: Plastimed Laboratoire Pharmaceutique
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 1997-12-15
Decision date: 1998-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.