KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH.— 510(k) K921054

Substantially Equivalent

Kendall Healthcare Products Co. Div.Of Tyco Health

FDA 510(k) clearance K921054 for KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH., Substantially Equivalent on 1992-09-23. Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health.

Clearance details

Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 1992-03-05
Decision date: 1992-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

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Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.