KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304— 510(k) K042461

Substantially Equivalent

Kendall

FDA 510(k) clearance K042461 for KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304, Substantially Equivalent on 2004-12-10. Applicant: Kendall.

Clearance details

Applicant: Kendall
Product code: Code LJS
Advisory panel: General Hospital
Date received: 2004-09-10
Decision date: 2004-12-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Mansfield, MA, US

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Adverse events under product code LJS

product code LJS

Death: 31
Injury: 2,791
Malfunction: 18,374
Other: 5
Total: 21,201

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.