K843785

Substantially Equivalent

WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR

Applicant: Intl. Medical Devices , Ltd.
Product code: BTO
Advisory panel: Anesthesiology
Date received: 1984-09-27
Decision date: 1984-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northridge, CA, US

Adverse events under product code BTO

product code BTO

Death: 14
Injury: 328
Malfunction: 1,851
Total: 2,193

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.