14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY— 510(k) K051584

Substantially Equivalent

Kendall

FDA 510(k) clearance K051584 for 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY, Substantially Equivalent on 2005-10-06. Applicant: Kendall.

Clearance details

Applicant: Kendall
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2005-06-15
Decision date: 2005-10-06
Decision: Substantially Equivalent
Clearance type: Special
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.