510(k) K895352— KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN

Substantially Equivalent

Kendall Healthcare Products Co. Div.Of Tyco Health

Clearance details

Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 1989-09-01
Decision date: 1989-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.