510(k) K903732— KENDALL SAFETRAK(TM) HIGH FLOW CATHETER

Unknown

Kendall Healthcare Products Co. Div.Of Tyco Health

Clearance details

Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 1990-08-16
Decision date: 1990-10-03
Decision: Unknown
Clearance type: Traditional
Location: Mansfield, MA, US

Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.