MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE— 510(k) K080821

Substantially Equivalent

Kimberly-Clark Corp.

FDA 510(k) clearance K080821 for MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE, Substantially Equivalent on 2008-04-22. Applicant: Kimberly-Clark Corp..

Clearance details

Applicant: Kimberly-Clark Corp.
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 2008-03-24
Decision date: 2008-04-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Roswell, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

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.