KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER— 510(k) K002901

Substantially Equivalent

The Kendall Company

FDA 510(k) clearance K002901 for KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER, Substantially Equivalent on 2001-03-28. Applicant: The Kendall Company.

Clearance details

Applicant: The Kendall Company
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2000-09-18
Decision date: 2001-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, 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.