MAHURKAR TRIPLE LUMEN CATHETER, 12 FR— 510(k) K020089

Substantially Equivalent

The Kendall Company

FDA 510(k) clearance K020089 for MAHURKAR TRIPLE LUMEN CATHETER, 12 FR, Substantially Equivalent on 2002-04-10. Applicant: The Kendall Company.

Clearance details

Applicant: The Kendall Company
Product code: Code NIE
Advisory panel: Gastroenterology, Urology
Date received: 2002-01-10
Decision date: 2002-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

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Adverse events under product code NIE

product code NIE

Death: 9
Other: 1
Total: 10

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.