TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT— 510(k) K091761

Substantially Equivalent

Teleflexmedical, Inc.

FDA 510(k) clearance K091761 for TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT, Substantially Equivalent on 2009-10-29. Applicant: Teleflexmedical, Inc..

Clearance details

Applicant: Teleflexmedical, Inc.
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 2009-06-16
Decision date: 2009-10-29
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Durham, NC, 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.