TRACHEAL TUBE W/ILLUMINATING LOCATER— 510(k) K830631

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K830631 for TRACHEAL TUBE W/ILLUMINATING LOCATER, Substantially Equivalent on 1983-05-09. Applicant: Mallinckrodt Critical Care.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 1983-03-01
Decision date: 1983-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.