510(k) K101721— WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

Substantially Equivalent

Regulatory and Marketing Services, Inc.

Clearance details

Applicant: Regulatory and Marketing Services, Inc.
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 2010-06-18
Decision date: 2011-03-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Appollo Beach, FL, 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.