MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR— 510(k) K000087

Substantially Equivalent

The Kendal Co.

FDA 510(k) clearance K000087 for MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR, Substantially Equivalent on 2000-03-17. Applicant: The Kendal Co..

Clearance details

Applicant: The Kendal Co.
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 2000-01-12
Decision date: 2000-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

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Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.