TRACHEOSTOMY TRAY— 510(k) K896798

Substantially Equivalent

Westmark, Sterile Packing Systems, Inc. (Sps)

FDA 510(k) clearance K896798 for TRACHEOSTOMY TRAY, Substantially Equivalent on 1990-02-22. Applicant: Westmark, Sterile Packing Systems, Inc. (Sps).

Clearance details

Applicant: Westmark, Sterile Packing Systems, Inc. (Sps)
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 1989-12-01
Decision date: 1990-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTO

product code BTO

Death: 14
Injury: 328
Malfunction: 1,851
Total: 2,193

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.