ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH— 510(k) K100480

Substantially Equivalent

Vitaltec Corporation

FDA 510(k) clearance K100480 for ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH, Substantially Equivalent on 2010-06-11. Applicant: Vitaltec Corporation.

Clearance details

Applicant: Vitaltec Corporation
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 2010-02-18
Decision date: 2010-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin Chu City, TW

Download summary PDF View on FDA.gov ↗

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.