510(k) K874450— SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT

Substantially Equivalent

Surgitech C/O Collier, Shannon, Rill & Scott

Clearance details

Applicant: Surgitech C/O Collier, Shannon, Rill & Scott
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 1987-10-29
Decision date: 1988-02-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.