AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)— 510(k) K080170

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K080170 for AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP), Substantially Equivalent on 2008-03-25. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 2008-01-24
Decision date: 2008-03-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Covington, GA, US

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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.