MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)— 510(k) K080339

Substantially Equivalent

Medsource International, LLC

FDA 510(k) clearance K080339 for MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF), Substantially Equivalent on 2008-10-27. Applicant: Medsource International, LLC.

Clearance details

Applicant: Medsource International, LLC
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 2008-02-08
Decision date: 2008-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, 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.