SHILEY SLEEP APNEA LOW PRESSURE CUFFED TRACH TUBE— 510(k) K861463

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K861463 for SHILEY SLEEP APNEA LOW PRESSURE CUFFED TRACH TUBE, Substantially Equivalent on 1986-05-06. Applicant: Shiley, Inc..

Clearance details

Applicant: Shiley, Inc.
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 1986-04-21
Decision date: 1986-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.