TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR— 510(k) K041006

Substantially Equivalent

Kendall

FDA 510(k) clearance K041006 for TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR, Substantially Equivalent on 2004-05-19. Applicant: Kendall.

Clearance details

Applicant: Kendall
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2004-04-19
Decision date: 2004-05-19
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.